Trial Outcomes & Findings for An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (NCT NCT03338790)
NCT ID: NCT03338790
Last Updated: 2026-01-27
Results Overview
Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
292 participants
Primary outcome timeframe
Up to approximately 36 months
Results posted on
2026-01-27
Participant Flow
292 participants treated
Participant milestones
| Measure |
Arm A1
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
71
|
84
|
49
|
|
Overall Study
COMPLETED
|
0
|
3
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
88
|
68
|
83
|
49
|
Reasons for withdrawal
| Measure |
Arm A1
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Overall Study
Disease Progression
|
65
|
46
|
54
|
42
|
|
Overall Study
Study Drug Toxicity
|
12
|
8
|
14
|
0
|
|
Overall Study
Death
|
2
|
1
|
1
|
0
|
|
Overall Study
Adverse Event unrelated to Study Drug
|
4
|
4
|
6
|
4
|
|
Overall Study
Participant request to discontinue study treatment
|
4
|
3
|
3
|
1
|
|
Overall Study
Poor/non-compliance
|
0
|
1
|
0
|
0
|
|
Overall Study
Participant withdrew consent
|
1
|
0
|
1
|
1
|
|
Overall Study
Other reasons
|
0
|
5
|
1
|
1
|
|
Overall Study
Maximum clinical benefit
|
0
|
0
|
1
|
0
|
|
Overall Study
Administrative reason by sponsor
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant no longer meets study criteria
|
0
|
0
|
1
|
0
|
Baseline Characteristics
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=71 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=49 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
5 Participants
n=50 Participants
|
5 Participants
n=152 Participants
|
25 Participants
n=614 Participants
|
|
Age, Continuous
|
66.6 Years
STANDARD_DEVIATION 8.3 • n=25 Participants
|
70.7 Years
STANDARD_DEVIATION 9.7 • n=25 Participants
|
70.3 Years
STANDARD_DEVIATION 7.6 • n=50 Participants
|
69.8 Years
STANDARD_DEVIATION 8.0 • n=152 Participants
|
69.4 Years
STANDARD_DEVIATION 8.4 • n=614 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=25 Participants
|
71 Participants
n=25 Participants
|
84 Participants
n=50 Participants
|
49 Participants
n=152 Participants
|
292 Participants
n=614 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
4 Participants
n=614 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
8 Participants
n=50 Participants
|
2 Participants
n=152 Participants
|
15 Participants
n=614 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=25 Participants
|
64 Participants
n=25 Participants
|
70 Participants
n=50 Participants
|
42 Participants
n=152 Participants
|
248 Participants
n=614 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 36 monthsPopulation: All response evaluable participants
Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease
Outcome measures
| Measure |
Arm A1
n=58 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=39 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=45 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=18 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Overall
|
10.3 Percentage of participants
Interval 3.9 to 21.2
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
40.0 Percentage of participants
Interval 25.7 to 55.7
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
|
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Homologous Recombination Deficiency (HRD+)
|
17.2 Percentage of participants
Interval 5.8 to 35.8
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
36.8 Percentage of participants
Interval 16.3 to 61.6
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
PRIMARY outcome
Timeframe: Up to approximately 36 monthsPopulation: All treated participants with baseline and at least one post-baseline PSA assessment
Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
Outcome measures
| Measure |
Arm A1
n=84 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=66 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=81 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=44 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Prostate-Specific Antigen Response Rate (RR-PSA)
Overall
|
11.9 Percentage of participants
Interval 5.9 to 20.8
|
27.3 Percentage of participants
Interval 17.0 to 39.6
|
46.9 Percentage of participants
Interval 35.7 to 58.3
|
34.1 Percentage of participants
Interval 20.5 to 49.9
|
|
Prostate-Specific Antigen Response Rate (RR-PSA)
Homologous Recombination Deficiency (HRD+)
|
18.2 Percentage of participants
Interval 8.2 to 32.7
|
41.9 Percentage of participants
Interval 24.5 to 60.9
|
50.0 Percentage of participants
Interval 32.4 to 67.6
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
SECONDARY outcome
Timeframe: Up to approximately 84 monthsPopulation: All treated participants
Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Outcome measures
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=71 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=49 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Radiographic Progression-Free Survival (rPFS)
Homologous Recombination Deficiency (HRD+)
|
5.59 Months
Interval 3.68 to 8.08
|
11.01 Months
Interval 6.74 to 12.02
|
10.45 Months
Interval 8.44 to 12.88
|
8.48 Months
Interval 3.78 to
Upper limit not reached due to too few events
|
|
Radiographic Progression-Free Survival (rPFS)
Overall
|
4.60 Months
Interval 3.68 to 5.72
|
8.15 Months
Interval 5.59 to 10.97
|
9.20 Months
Interval 8.25 to 11.47
|
5.75 Months
Interval 3.81 to 9.33
|
SECONDARY outcome
Timeframe: Up to approximately 84 monthsPopulation: All response evaluable participants (CR or PR)
Time to response per prostate cancer clinical trials working group 3 (TTR-PCWG3) is the time from treatment initiation to the date of the first documented complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Outcome measures
| Measure |
Arm A1
n=7 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=6 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=21 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=2 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
Overall
|
1.94 Months
Interval 1.6 to 5.1
|
1.95 Months
Interval 1.8 to 11.0
|
1.94 Months
Interval 1.6 to 8.3
|
1.9 Months
Interval 1.9 to 1.9
|
|
Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
Homologous Recombination Deficiency (HRD+)
|
2.76 Months
Interval 1.6 to 5.1
|
2.07 Months
Interval 1.8 to 11.0
|
2.04 Months
Interval 1.8 to 8.3
|
1.9 Months
Interval 1.9 to 1.9
|
SECONDARY outcome
Timeframe: Up to approximately 84 monthsPopulation: All response evaluable participants (CR or PR)
Duration of response per prostate cancer clinical trials working group 3 (DOR-PCWG3) is the time between the date of first response (complete response/partial response per PCWG3) to the date of first documented radiographic progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) or death due to any cause
Outcome measures
| Measure |
Arm A1
n=7 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=6 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=21 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=2 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
Overall
|
NA Months
Interval 3.45 to
Median and upper limit not reached due to too few events
|
7.10 Months
Interval 3.78 to
Upper limit not reached due to too few events
|
7.21 Months
Interval 6.47 to 12.35
|
NA Months
Interval 9.23 to
Median and upper limit not reached due to too few events
|
|
Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
Homologous Recombination Deficiency (HRD+)
|
NA Months
Interval 3.45 to
Median and upper limit not reached due to too few events
|
7.10 Months
Interval 3.78 to
Upper limit not reached due to too few events
|
7.43 Months
Interval 6.44 to 13.86
|
NA Months
Median and upper limit not reached due to too few events
|
SECONDARY outcome
Timeframe: Up to approximately 84 monthsPopulation: All PSA response evaluable participants
Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trials working group 3 (PCWG3)
Outcome measures
| Measure |
Arm A1
n=85 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=66 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=81 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=44 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Prostate-Specific Antigen Time to Progression (TTP-PSA)
Overall
|
3.78 Months
Interval 2.83 to 6.47
|
3.45 Months
Interval 2.83 to 6.21
|
8.67 Months
Interval 7.16 to 10.35
|
3.09 Months
Interval 2.79 to 6.37
|
|
Prostate-Specific Antigen Time to Progression (TTP-PSA)
Homologous Recombination Deficiency (HRD+)
|
6.47 Months
Interval 3.78 to 9.63
|
10.25 Months
Interval 4.63 to 13.77
|
8.64 Months
Interval 7.16 to 10.58
|
5.55 Months
Interval 2.73 to 8.28
|
SECONDARY outcome
Timeframe: Up to approximately 84 monthsPopulation: All treated participants
Overall Survival (OS) is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of treatment initiation if they had no follow-up
Outcome measures
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=71 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=49 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Overall Survival (OS)
Overall
|
13.96 Months
Interval 10.35 to 15.77
|
20.24 Months
Interval 13.54 to 22.9
|
18.17 Months
Interval 15.15 to 25.49
|
17.41 Months
Interval 12.98 to 24.15
|
|
Overall Survival (OS)
Homologous Recombination Deficiency (HRD+)
|
15.15 Months
Interval 11.4 to 18.2
|
23.00 Months
Interval 13.54 to 29.27
|
19.35 Months
Interval 13.54 to 27.2
|
24.97 Months
Interval 9.1 to 45.5
|
SECONDARY outcome
Timeframe: From first dose to up to 30 days post last dose (Up to 82 months)Population: All treated participants
Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4)
Outcome measures
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=71 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=49 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Pneumonitis)
|
1 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Diarrhea/Colitis)
|
3 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Hepatitis)
|
8 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Nephritis/Renal Dysfunction)
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Rash)
|
6 Participants
|
5 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Hypersensitivity)
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Adrenal insufficiency)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Diabetes Mellitus)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Hypothyroidism/Thyroiditis)
|
7 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Hyperthyroidism)
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Immune-mediated AEs (Hypophysitis)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse Events (AEs)
|
88 Participants
|
71 Participants
|
83 Participants
|
49 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious Adverse Events (SAEs)
|
49 Participants
|
37 Participants
|
41 Participants
|
20 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation
|
47 Participants
|
31 Participants
|
37 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 84 monthsPopulation: All treated participants
Number of participants who died due to any cause.
Outcome measures
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=71 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=49 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Number of Participants Who Died
|
79 Participants
|
66 Participants
|
76 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: From first dose to up to 30 days post last dose (up to 82 months)Population: All treated participant with at least one on-treatment measurement of the corresponding laboratory parameter
Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * ALP \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
Outcome measures
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=69 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=48 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 3xULN
|
19 Participants
|
23 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 5xULN
|
11 Participants
|
15 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 10xULN
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 20xULN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
TOTAL BILIRUBIN > 2xULN
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALP > 1.5xULN
|
49 Participants
|
34 Participants
|
35 Participants
|
22 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within one day
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within 30 days
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within one day
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within 30 days
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to up to 30 days post last dose (Up to 82 months)Population: All treated participants with thyroid stimulating hormone (TSH) abnormality
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * TSH value \> ULN and * with baseline TSH value \<= ULN * with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test. * TSH \< LLN and * with baseline TSH value \>= LLN * with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test
Outcome measures
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=71 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=49 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN
|
23 Participants
|
17 Participants
|
12 Participants
|
17 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with TSH <= ULN at baseline
|
18 Participants
|
12 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with at least one FT3/FT4 test value < LLN
|
10 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with all other FT3/FT4 test values >= LLN
|
11 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with FT3/FT4 test missing
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN
|
17 Participants
|
12 Participants
|
25 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with TSH >= LLN at baseline
|
14 Participants
|
11 Participants
|
19 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with at least one FT3/FT4 test value > ULN
|
6 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with all other FT3/FT4 test values <= ULN
|
8 Participants
|
4 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with FT3/FT4 test missing
|
3 Participants
|
3 Participants
|
12 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose to up to 30 days post last dose (Up to 82 months)Population: All treated participants
Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort
Outcome measures
| Measure |
Arm A1
n=88 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=71 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=84 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=49 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Values Change From Baseline
Leukocytes Grade 1
|
10 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Leukocytes Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Values Change From Baseline
Lymphocytes Grade 0
|
24 Participants
|
30 Participants
|
28 Participants
|
14 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Lymphocytes Grade 1
|
11 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Lymphocytes Grade 2
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Lymphocytes Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Values Change From Baseline
Neutrophil Grade 0
|
35 Participants
|
26 Participants
|
38 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Neutrophil Grade 1
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Values Change From Baseline
Neutrophil Grade 2
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Alkaline Phosphatase Grade 0
|
25 Participants
|
34 Participants
|
13 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Alkaline Phosphatase Grade 1
|
14 Participants
|
4 Participants
|
13 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Alkaline Phosphatase Grade 2
|
9 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Alkaline Phosphatase Grade 3
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Aspartate Aminotransferase Grade 0
|
52 Participants
|
49 Participants
|
16 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Aspartate Aminotransferase Grade 1
|
5 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Alanine Aminotransferase Grade 0
|
48 Participants
|
48 Participants
|
13 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Alanine Aminotransferase Grade 1
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Bilirubin Grade 0
|
16 Participants
|
12 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Bilirubin Grade 1
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Creatinine Grade 0
|
31 Participants
|
30 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Creatinine Grade 1
|
7 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Platelet Grade 0
|
34 Participants
|
32 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Platelet Grade 1
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Leukocytes Grade 0
|
39 Participants
|
35 Participants
|
30 Participants
|
13 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Hemoglobin Grade 0
|
23 Participants
|
21 Participants
|
30 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Hemoglobin Grade 1
|
38 Participants
|
28 Participants
|
23 Participants
|
13 Participants
|
|
Number of Participants With Laboratory Values Change From Baseline
Hemoglobin Grade 2
|
8 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
POST_HOC outcome
Timeframe: Up to approximately 82 monthsPopulation: All response evaluable participants
Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease
Outcome measures
| Measure |
Arm A1
n=58 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=39 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=45 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=18 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) - Extended Collection
Overall
|
12.1 Percentage of participants
Interval 5.0 to 23.3
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
40.0 Percentage of participants
Interval 25.7 to 55.7
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
|
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) - Extended Collection
Homologous Recombination Deficiency (HRD+)
|
20.7 Percentage of participants
Interval 8.0 to 39.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
36.8 Percentage of participants
Interval 16.3 to 61.6
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
POST_HOC outcome
Timeframe: Up to approximately 82 monthsPopulation: All response evaluable participants
Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
Outcome measures
| Measure |
Arm A1
n=85 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2
n=66 Participants
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
Arm B
n=81 Participants
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C
n=44 Participants
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
|---|---|---|---|---|
|
Prostate-Specific Antigen Response Rate (RR-PSA) - Extended Collection
Overall
|
11.8 Percentage of participants
Interval 5.8 to 20.6
|
28.8 Percentage of participants
Interval 18.3 to 41.3
|
46.9 Percentage of participants
Interval 35.7 to 58.3
|
34.1 Percentage of participants
Interval 20.5 to 49.9
|
|
Prostate-Specific Antigen Response Rate (RR-PSA) - Extended Collection
Homologous Recombination Deficiency (HRD+)
|
18.2 Percentage of participants
Interval 8.2 to 32.7
|
43.8 Percentage of participants
Interval 26.4 to 62.3
|
50.0 Percentage of participants
Interval 32.4 to 67.6
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
Adverse Events
Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2
Serious events: 50 serious events
Other events: 83 other events
Deaths: 76 deaths
Arm C: Nivolumab 480 mg and Enzalutamide 160 mg
Serious events: 25 serious events
Other events: 48 other events
Deaths: 47 deaths
Arm A1: Nivolumab 480 mg and Rucaparib 600 mg
Serious events: 53 serious events
Other events: 87 other events
Deaths: 79 deaths
Arm A2: Nivolumab 480 mg and Rucaparib 600 mg
Serious events: 45 serious events
Other events: 70 other events
Deaths: 66 deaths
Serious adverse events
| Measure |
Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2
n=84 participants at risk
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C: Nivolumab 480 mg and Enzalutamide 160 mg
n=49 participants at risk
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
Arm A1: Nivolumab 480 mg and Rucaparib 600 mg
n=88 participants at risk
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2: Nivolumab 480 mg and Rucaparib 600 mg
n=71 participants at risk
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.1%
8/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Endocrine disorders
Adrenal insufficiency
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
3/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Asthenia
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Death
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Fatigue
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
General physical health deterioration
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Pain
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Pyrexia
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Atypical pneumonia
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Febrile infection
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Infection
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Influenza
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Neutropenic infection
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Pneumonia
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Pulmonary sepsis
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Rectal abscess
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Sepsis
|
3.6%
3/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Septic shock
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Urosepsis
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Vascular anastomosis aneurysm
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
General physical condition abnormal
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Liver function test abnormal
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Liver function test increased
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Neutrophil count decreased
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
9.5%
8/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
14.3%
7/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
15.9%
14/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Presyncope
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Seizure
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Syncope
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Product issues
Device occlusion
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Psychiatric disorders
Abnormal behaviour
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.0%
7/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Ureteric compression
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Urinoma
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Cutaneous sarcoidosis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Embolism
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Haematoma
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Lymphatic fistula
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Lymphoedema
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
Other adverse events
| Measure |
Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2
n=84 participants at risk
Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
|
Arm C: Nivolumab 480 mg and Enzalutamide 160 mg
n=49 participants at risk
Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
|
Arm A1: Nivolumab 480 mg and Rucaparib 600 mg
n=88 participants at risk
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
|
Arm A2: Nivolumab 480 mg and Rucaparib 600 mg
n=71 participants at risk
Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
29.8%
25/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
30.6%
15/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
36.4%
32/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
42.3%
30/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.7%
5/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
14/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
15.9%
14/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.5%
11/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
11.3%
8/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
10.2%
5/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.0%
7/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
13.1%
11/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
10.2%
9/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Constipation
|
25.0%
21/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
20.4%
10/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
29.5%
26/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
25.4%
18/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
42/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
18.4%
9/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
33.0%
29/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
29.6%
21/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Nausea
|
42.9%
36/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
34.7%
17/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
52.3%
46/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
49.3%
35/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
14/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
10.2%
5/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
34.1%
30/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
25.4%
18/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Asthenia
|
20.2%
17/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
22.4%
11/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
27.3%
24/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
16.9%
12/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Chills
|
10.7%
9/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Fatigue
|
48.8%
41/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
42.9%
21/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
40.9%
36/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
36.6%
26/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Mucosal inflammation
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.1%
8/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Oedema peripheral
|
23.8%
20/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
20.4%
10/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
19.3%
17/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
21.1%
15/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Pain
|
3.6%
3/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
14.3%
7/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.8%
6/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
General disorders and administration site conditions
Pyrexia
|
15.5%
13/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
17.0%
15/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Bronchitis
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.7%
5/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Pneumonia
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.8%
6/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Infections and infestations
Urinary tract infection
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.7%
5/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
18.2%
16/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
29.6%
21/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
14.3%
7/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
17.0%
15/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
29.6%
21/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
10.2%
5/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.1%
8/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Blood creatinine increased
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.1%
8/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
28.2%
20/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Neutrophil count decreased
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Transaminases increased
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Investigations
Weight decreased
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
10.2%
5/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
10.2%
9/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.8%
25/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
28.6%
14/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
33.0%
29/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
29.6%
21/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.2%
6/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.8%
20/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
32.7%
16/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
19.3%
17/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
15.5%
11/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
29.8%
25/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
24.5%
12/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
22.7%
20/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
15.5%
11/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.5%
8/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
22.4%
11/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
13.6%
12/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.8%
6/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
10.2%
5/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.9%
10/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
22.4%
11/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.0%
7/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.9%
7/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Dizziness
|
20.2%
17/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.2%
6/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.0%
7/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Dysgeusia
|
14.3%
12/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.2%
6/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.5%
11/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Headache
|
11.9%
10/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.2%
6/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.1%
8/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
27.4%
23/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Paraesthesia
|
3.6%
3/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Nervous system disorders
Syncope
|
3.6%
3/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
6.1%
3/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.4%
1/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Psychiatric disorders
Depression
|
2.4%
2/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Psychiatric disorders
Insomnia
|
10.7%
9/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
16.3%
8/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
9.1%
8/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.7%
5/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Haematuria
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.0%
7/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Renal and urinary disorders
Urinary retention
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
3.4%
3/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
21/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
17.0%
15/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
15.5%
11/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.8%
20/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
14.8%
13/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.1%
2/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.5%
8/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
28/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
3/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.7%
5/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
7.0%
5/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.5%
4/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
8.3%
7/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
6/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
18.4%
9/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
11.4%
10/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
15.5%
11/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.0%
16/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.2%
6/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
11.4%
10/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
12.7%
9/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
1.1%
1/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.8%
2/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.2%
1/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
0.00%
0/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.3%
2/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.6%
4/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Hypertension
|
6.0%
5/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.2%
4/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
5.7%
5/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
4.2%
3/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
|
Vascular disorders
Hypotension
|
4.8%
4/84 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
2.0%
1/49 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.0%
7/88 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
8.5%
6/71 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).
|
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