Trial Outcomes & Findings for A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder (NCT NCT03519256)
NCT ID: NCT03519256
Last Updated: 2023-06-01
Results Overview
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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Results posted on
2023-06-01
Participant Flow
A safety lead-in was conducted in participants randomized to receive bacillus Calmette-Guerin (BCG) and nivolumab without BMS-986205 (Arm B), and Nivolumab Plus BMS-986205 Plus Intravesical BCG (Arm D) to determine safe-dose levels to be administered during the treatment phase.
Participant milestones
| Measure |
Arm A: Nivolumab
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
26
|
17
|
10
|
|
Overall Study
Safety-Lead In Phase
|
0
|
10
|
0
|
10
|
|
Overall Study
COMPLETED
|
6
|
15
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
15
|
7
|
Reasons for withdrawal
| Measure |
Arm A: Nivolumab
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Overall Study
Disease recurrence
|
4
|
4
|
5
|
2
|
|
Overall Study
Study drug toxicity
|
0
|
2
|
5
|
2
|
|
Overall Study
Adverse event unrelated to study drug
|
0
|
1
|
1
|
0
|
|
Overall Study
Participant request to discontinue study treatment
|
0
|
0
|
0
|
2
|
|
Overall Study
Other reasons
|
0
|
0
|
2
|
0
|
|
Overall Study
Disease progression
|
6
|
3
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
Baseline characteristics by cohort
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
69.0 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
69.1 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
69.9 Years
STANDARD_DEVIATION 16.4 • n=4 Participants
|
67.5 Years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication.
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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
15 Participants
|
26 Participants
|
15 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication.
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Requires inpatient hospitalization or causes prolongation of existing hospitalization. SAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
2 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication.
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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs leading to discontinuation are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment
|
1 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication.
IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity IMAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants Immune-Mediated Adverse Events (IMAEs)
|
1 Participants
|
10 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)Population: All randomized participants who received at least one dose of any study medication.
Number of participants who died.
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants Who Died
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication and had at least one on-treatment liver laboratory measurement.
On-treatment laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal.
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALP>1.5XULN
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT OR AST > 3XULN
|
0 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT OR AST> 5XULN
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT OR AST> 10XULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Specific Liver Laboratory Abnormalities
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication and had at least one on-treatment thyroid laboratory measurement.
On-treatment laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH > ULN WITH TSH <= ULN AT BASELINE
|
4 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH > ULN
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH > ULN WITH FT3/FT4 TEST MISSING
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH < LLN
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH <LLN WITH TSH >= LLN AT BASELINE
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Specific Thyroid Laboratory Abnormalities
TSH < LLN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication and had at least one on-study select laboratory measurement.
On-study laboratory parameters include hematology, chemistry, liver function, and renal function. On-study laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment. On-study lab parameters are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Arm A: Nivolumab
n=16 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Changes From Baseline Laboratory Values
Hemoglobin
|
1 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Platelet Count
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Leukocytes, Local Lab
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Lymphocytes (Absolute)
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Lymphocytes (Absolute), Local Lab
|
2 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Absolute Neutrophil Count
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Alkaline Phosphatase (ALP), Local Lab
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Aspartate Aminotransferase (AST), Local Lab
|
3 Participants
|
5 Participants
|
12 Participants
|
3 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Alanine Aminotransferase (ALT), Local Lab
|
4 Participants
|
10 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Bilirubin Total, Local Lab
|
1 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Creatinine, Local Lab
|
1 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hypernatremia
|
0 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hyponatremia
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hyperkalemia
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hypokalemia
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hypercalcemia
|
2 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hypocalcemia
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hypermagnesemia
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hypomagnesemia
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hyperglycemia
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline Laboratory Values
Hypoglycemia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication and had evaluable ADA status.
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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug. An ADA-positive participant has at least one ADA positive-sample relative to baseline at any time after initiation of treatment An ADA-negative participant doesn't not have an ADA-positive sample after the initiation of treatment.
Outcome measures
| Measure |
Arm A: Nivolumab
n=11 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=22 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=13 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=9 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status
Nivolumab ADA Positive
|
—
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status
Nivolumab ADA Negative
|
11 Participants
|
21 Participants
|
11 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)Population: All randomized participants who received at least one dose of any study medication and had evaluable ADA status.
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Requires inpatient hospitalization or causes prolongation of existing hospitalization. An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug. An ADA-positive participant has at least one ADA positive-sample relative to baseline at any time after initiation of treatment An ADA-negative participant doesn't not have an ADA-positive sample after the initiation of treatment.
Outcome measures
| Measure |
Arm A: Nivolumab
n=11 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=22 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=13 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=9 Participants
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status
Nivolumab ADA Positive
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status
Nivolumab ADA Negative
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
Adverse Events
Arm A: Nivolumab
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm B: Nivolumab Plus Intravesical BCG
Serious events: 7 serious events
Other events: 26 other events
Deaths: 3 deaths
Arm C: Nivolumab Plus BMS-986205
Serious events: 7 serious events
Other events: 15 other events
Deaths: 2 deaths
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Nivolumab
n=16 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Death
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Disease recurrence
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Wound infection
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
18.8%
3/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
Other adverse events
| Measure |
Arm A: Nivolumab
n=16 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
|
Arm B: Nivolumab Plus Intravesical BCG
n=26 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
|
Arm C: Nivolumab Plus BMS-986205
n=17 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
|
Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG
n=10 participants at risk
Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
3/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Endocrine disorders
Hypothyroidism
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.5%
3/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Eye disorders
Diplopia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
17.6%
3/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
3/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
15.4%
4/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
23.5%
4/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.5%
3/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Ileus
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.5%
3/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
30.0%
3/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Asthenia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Chills
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Fatigue
|
18.8%
3/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
34.6%
9/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
17.6%
3/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
40.0%
4/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
50.0%
5/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Localised oedema
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Oedema peripheral
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Pyrexia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
General disorders
Thirst
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Candida infection
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Cystitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Device related infection
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Ear infection
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Groin infection
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Herpes zoster
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Nail infection
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Orchitis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
34.6%
9/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
30.0%
3/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Infections and infestations
Wound infection
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
30.0%
3/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
2/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Stoma site hypergranulation
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Injury, poisoning and procedural complications
Vascular access site rash
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
23.5%
4/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
40.0%
4/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Amylase increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Antinuclear antibody positive
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
29.4%
5/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
40.0%
4/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
40.0%
4/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood methaemoglobin present
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
12.5%
2/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood triglycerides increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood uric acid increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Blood urine present
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Heart rate irregular
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Lipase increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Neutrophil count increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Neutrophil percentage increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
PCO2 increased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Transaminases increased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Investigations
Weight decreased
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
2/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
31.2%
5/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.8%
3/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
2/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
23.1%
6/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
19.2%
5/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
30.0%
3/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
19.2%
5/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.5%
3/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Nervous system disorders
Sinus headache
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.8%
2/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.5%
3/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
38.5%
10/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
40.0%
4/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Haematuria
|
25.0%
4/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
42.3%
11/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
23.5%
4/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
50.0%
5/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Hypertonic bladder
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
26.9%
7/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
40.0%
4/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
2/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
30.8%
8/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
70.0%
7/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Renal failure
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Strangury
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Urethral pain
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.5%
3/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
15.4%
4/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
3/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
23.1%
6/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
17.6%
3/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
11.5%
3/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
20.0%
2/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
7.7%
2/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Vascular disorders
Flushing
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
3.8%
1/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
5.9%
1/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
6.2%
1/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/16 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/26 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
0.00%
0/17 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
10.0%
1/10 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 48 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (an average of 45 weeks up to approximately 74 weeks).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER