Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (NCT NCT02632409)
NCT ID: NCT02632409
Last Updated: 2025-10-16
Results Overview
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
709 participants
Primary outcome timeframe
approximately up to 48 months
Results posted on
2025-10-16
Participant Flow
709 Participants Randomized, 699 Treated
Participant milestones
| Measure |
Placebo
Placebo
|
Nivolumab
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Randomized
STARTED
|
356
|
353
|
|
Randomized
COMPLETED
|
348
|
351
|
|
Randomized
NOT COMPLETED
|
8
|
2
|
|
Treatment Period
STARTED
|
348
|
351
|
|
Treatment Period
COMPLETED
|
132
|
143
|
|
Treatment Period
NOT COMPLETED
|
216
|
208
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
|
Nivolumab
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Randomized
AE unrelated to study Drug
|
0
|
1
|
|
Randomized
Participant withdrew consent
|
2
|
1
|
|
Randomized
No Longer meets study criteria
|
5
|
0
|
|
Randomized
other reasons
|
1
|
0
|
|
Treatment Period
Ongoing Treatment
|
20
|
21
|
|
Treatment Period
Disease Recurrence
|
147
|
90
|
|
Treatment Period
Study Drug Toxicity
|
8
|
49
|
|
Treatment Period
Death
|
1
|
0
|
|
Treatment Period
AE unrelated to study drug
|
15
|
16
|
|
Treatment Period
Request to discontinue treatment
|
4
|
19
|
|
Treatment Period
Participant withdrew consent
|
7
|
5
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Treatment Period
Maximum clinical benefit
|
1
|
0
|
|
Treatment Period
No longer meets study criteria
|
3
|
0
|
|
Treatment Period
Administrative Reason by sponsor
|
0
|
1
|
|
Treatment Period
Other Reasons
|
10
|
6
|
Baseline Characteristics
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=356 Participants
Placebo
|
Nivolumab
n=353 Participants
Nivolumab 240mg IV Q2W
|
Total
n=709 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
65.3 Years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
65.6 Years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=99 Participants
|
265 Participants
n=107 Participants
|
540 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
192 Participants
n=99 Participants
|
195 Participants
n=107 Participants
|
387 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
75 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
272 Participants
n=99 Participants
|
264 Participants
n=107 Participants
|
536 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: approximately up to 48 monthsPopulation: All Randomized Participants
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo
|
Nivolumab
n=353 Participants
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Disease Free Survival (DFS)
|
10.84 Months
Interval 8.25 to 13.86
|
20.76 Months
Interval 16.49 to 27.63
|
PRIMARY outcome
Timeframe: approximately up to 48 monthsPopulation: All Randomized Participants with PD-L1 expression ≥ 1%
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo
n=142 Participants
Placebo
|
Nivolumab
n=140 Participants
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
|
8.41 Months
Interval 5.59 to 21.19
|
NA Months
Interval 22.01 to
Insufficient number of events to calculate median value. Upper limit number not reached
|
SECONDARY outcome
Timeframe: up to 53 monthsPopulation: All Randomized Participants
The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo
|
Nivolumab
n=353 Participants
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Non-Urothelial Tract Recurrence Free Survival
|
13.70 Months
Interval 8.41 to 20.34
|
22.93 Months
Interval 19.15 to 33.41
|
SECONDARY outcome
Timeframe: up to 53 monthsPopulation: All Randomized Participants with PD-L1 expression ≥ 1%
The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo
n=142 Participants
Placebo
|
Nivolumab
n=140 Participants
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
|
10.84 Months
Interval 5.65 to 22.14
|
NA Months
Interval 24.57 to
Insufficient number of events to calculate median value. Upper limit number not reached
|
SECONDARY outcome
Timeframe: on goingthe time from randomization to the date of death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: on goingthe time from randomization to the date of death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: on goingthe time from randomization to the date of death due to disease (urothelial cancer).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: on goingthe time from randomization to the date of death due to disease (urothelial cancer).
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 129 serious events
Other events: 307 other events
Deaths: 0 deaths
Nivolumab
Serious events: 122 serious events
Other events: 332 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=348 participants at risk
Placebo
|
Nivolumab
n=351 participants at risk
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Cardiac failure
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Colitis
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
1.1%
4/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Enterocele
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
6/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
1.4%
5/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Necrotising oesophagitis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Pouchitis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
5/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Catheter site extravasation
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Complication associated with device
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Fatigue
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Generalised oedema
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Pain
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Pyrexia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Sudden death
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Hepatobiliary disorders
Hepatitis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Abscess limb
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Appendicitis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Bacteraemia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Bronchiolitis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Device related infection
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Diverticulitis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Infection
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Influenza
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Klebsiella infection
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Penile infection
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Peritonitis
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Pneumonia
|
1.4%
5/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Pyelonephritis
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Pyelonephritis acute
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Sepsis
|
1.1%
4/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
1.4%
5/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Septic encephalopathy
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Septic shock
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Skin infection
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
21/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
3.4%
12/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Urosepsis
|
2.6%
9/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Wound infection
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Hypobarism
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Penetrating abdominal trauma
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Amylase increased
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Blood bilirubin increased
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Blood magnesium decreased
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Clostridium test positive
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Lipase increased
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Platelet count decreased
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Transaminases increased
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
11.2%
39/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
4.3%
15/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent cancer
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract carcinoma in situ
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Cerebral infarction
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Seizure
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Syncope
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Product Issues
Device malfunction
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.86%
3/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
1.7%
6/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Haematuria
|
0.86%
3/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.1%
4/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Renal failure
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.4%
5/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.57%
2/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
1.7%
6/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.85%
3/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.28%
1/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Vascular disorders
Venous thrombosis limb
|
0.29%
1/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
0.00%
0/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
Other adverse events
| Measure |
Placebo
n=348 participants at risk
Placebo
|
Nivolumab
n=351 participants at risk
Nivolumab 240mg IV Q2W
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
8.9%
31/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
8.8%
31/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
41/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
15.1%
53/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Endocrine disorders
Hyperthyroidism
|
1.1%
4/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
10.5%
37/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
9/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
11.7%
41/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
42/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
10.5%
37/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Constipation
|
16.4%
57/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
14.2%
50/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.4%
92/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
29.9%
105/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Dry mouth
|
0.57%
2/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
5.7%
20/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Gastrointestinal disorders
Nausea
|
14.9%
52/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
17.9%
63/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Asthenia
|
8.9%
31/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
12.0%
42/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Fatigue
|
25.6%
89/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
28.2%
99/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Oedema peripheral
|
7.5%
26/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
9.1%
32/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
General disorders
Pyrexia
|
11.5%
40/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
10.5%
37/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
25/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
6.6%
23/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
26/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
8.8%
31/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Infections and infestations
Urinary tract infection
|
15.8%
55/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
19.4%
68/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Alanine aminotransferase increased
|
4.9%
17/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
6.6%
23/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Amylase increased
|
8.3%
29/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
13.1%
46/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Aspartate aminotransferase increased
|
4.9%
17/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
5.4%
19/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.6%
9/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
5.1%
18/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Blood creatinine increased
|
14.1%
49/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
14.5%
51/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Investigations
Lipase increased
|
8.6%
30/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
11.4%
40/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.6%
30/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
14.0%
49/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.2%
25/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
5.4%
19/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.5%
26/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
6.0%
21/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
45/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
11.4%
40/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
44/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
13.4%
47/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
12/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
6.3%
22/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
21/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
6.8%
24/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Dizziness
|
8.3%
29/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
9.1%
32/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Nervous system disorders
Headache
|
8.6%
30/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
9.4%
33/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Psychiatric disorders
Insomnia
|
4.9%
17/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
6.8%
24/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.2%
39/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
13.7%
48/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.0%
21/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
12.0%
42/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.6%
16/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
7.1%
25/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.1%
56/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
30.5%
107/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
36/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
19.1%
67/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.6%
9/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
6.3%
22/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
|
Vascular disorders
Hypertension
|
5.5%
19/348 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
4.6%
16/351 • appoximately up to 55 months
All Treated Participants All cause mortality is currently blinded at this time and will not be reported.
|
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
- Publication restrictions are in place
Restriction type: LTE60