Trial Outcomes & Findings for A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037) (NCT NCT01721746)
NCT ID: NCT01721746
Last Updated: 2022-04-19
Results Overview
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
Results posted on
2022-04-19
Participant Flow
405 participants randomized and 370 treated.
Participant milestones
| Measure |
Nivolumab
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Pre-Treatment
STARTED
|
272
|
133
|
|
Pre-Treatment
COMPLETED
|
268
|
102
|
|
Pre-Treatment
NOT COMPLETED
|
4
|
31
|
|
Treatment
STARTED
|
268
|
102
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
268
|
102
|
Reasons for withdrawal
| Measure |
Nivolumab
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Pre-Treatment
Participant request to discontinue Study treatment
|
0
|
13
|
|
Pre-Treatment
Withdrawal by Subject
|
1
|
16
|
|
Pre-Treatment
Poor/Non-compliance
|
1
|
0
|
|
Pre-Treatment
Participant no longer met study criteria
|
2
|
2
|
|
Treatment
Disease Progression
|
192
|
74
|
|
Treatment
Study Drug Toxicity
|
19
|
11
|
|
Treatment
Adverse Event unrelated to Study Drug
|
6
|
3
|
|
Treatment
Participant request to discontinue Study treatment
|
26
|
7
|
|
Treatment
Participant withdrew consent
|
4
|
2
|
|
Treatment
Maximum Clinical Benefit
|
9
|
3
|
|
Treatment
Poor/Non-compliance
|
2
|
0
|
|
Treatment
Participant no longer met Study criteria
|
4
|
0
|
|
Treatment
Other reasons
|
6
|
2
|
Baseline Characteristics
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Baseline characteristics by cohort
| Measure |
Nivolumab
n=272 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=133 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
152 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
269 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)Population: All randomized participants
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
Outcome measures
| Measure |
Nivolumab
n=272 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=133 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Objective Response Rate (ORR)
|
27.2 Percentage of participants
Interval 22.0 to 32.9
|
9.8 Percentage of participants
Interval 5.3 to 16.1
|
PRIMARY outcome
Timeframe: Up to 96 monthsPopulation: All randomized participants
Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
Outcome measures
| Measure |
Nivolumab
n=272 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=133 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Overall Survival (OS)
|
15.74 Months
Interval 12.88 to 19.88
|
14.39 Months
Interval 11.66 to 18.17
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)Population: All randomized participants
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
Outcome measures
| Measure |
Nivolumab
n=272 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=133 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Progression Free Survival (PFS)
|
3.12 months
Interval 2.33 to 3.52
|
3.65 months
Interval 2.3 to 5.29
|
SECONDARY outcome
Timeframe: From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)Population: All PD-L1 Evaluable Participants for ORR
Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
Outcome measures
| Measure |
Nivolumab
n=267 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=131 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Objective Response Rate (ORR) by Baseline PD-L1 Expression
<5% PD-L1 expression
|
15.3 Percentage of participants
Interval 9.7 to 22.5
|
13.8 Percentage of participants
Interval 6.1 to 25.4
|
|
Objective Response Rate (ORR) by Baseline PD-L1 Expression
>=5% PD-L1 expression
|
43.2 Percentage of participants
Interval 33.9 to 53.0
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
SECONDARY outcome
Timeframe: Up to 96 monthsPopulation: All PD-L1 positive evaluable participants for OS
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Nivolumab
n=135 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=67 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Overall Survival (OS) by PD-L1 Positive
|
31.44 Months
Interval 20.57 to 46.69
|
16.72 Months
Interval 11.83 to 31.44
|
SECONDARY outcome
Timeframe: Up to 96 monthsPopulation: All PD-L1 negative evaluable participants for OS
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Nivolumab
n=137 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=66 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Overall Survival (OS) by PD-L1 Negative
|
11.14 Months
Interval 7.72 to 13.21
|
11.76 Months
Interval 8.05 to 17.81
|
SECONDARY outcome
Timeframe: From Baseline (Day1) to second Follow-Up (Up to 96 months)Population: All randomized participants
Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.
Outcome measures
| Measure |
Nivolumab
n=272 Participants
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=133 Participants
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Role Functioning Follow-Up 1
|
-14.94 Units on a scale
Standard Deviation 31.13
|
-15.91 Units on a scale
Standard Deviation 29.76
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Global Health Status Follow-Up 2
|
-1.61 Units on a scale
Standard Deviation 18.53
|
-3.27 Units on a scale
Standard Deviation 12.07
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Dyspnea Follow-Up 1
|
6.06 Units on a scale
Standard Deviation 27.96
|
16.67 Units on a scale
Standard Deviation 24.67
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Dyspnea Follow-Up 2
|
5.91 Units on a scale
Standard Deviation 22.20
|
7.14 Units on a scale
Standard Deviation 24.61
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Insomnia Follow-Up 1
|
3.46 Units on a scale
Standard Deviation 32.26
|
0.00 Units on a scale
Standard Deviation 30.86
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Insomnia Follow-Up 2
|
-4.84 Units on a scale
Standard Deviation 25.50
|
0.00 Units on a scale
Standard Deviation 30.09
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Apatite loss Follow-Up 1
|
6.93 Units on a scale
Standard Deviation 28.79
|
13.64 Units on a scale
Standard Deviation 24.47
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Apatite loss Follow-Up 2
|
5.91 Units on a scale
Standard Deviation 30.49
|
2.38 Units on a scale
Standard Deviation 22.09
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Constipation Follow-Up 1
|
7.36 Units on a scale
Standard Deviation 28.93
|
0.00 Units on a scale
Standard Deviation 23.57
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Constipation Follow-Up 2
|
2.15 Units on a scale
Standard Deviation 22.48
|
-2.38 Units on a scale
Standard Deviation 29.99
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Diarrhea Follow-Up 1
|
-0.43 Units on a scale
Standard Deviation 19.86
|
6.35 Units on a scale
Standard Deviation 22.65
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Diarrhea Follow-Up 2
|
1.08 Units on a scale
Standard Deviation 20.88
|
1.19 Units on a scale
Standard Deviation 16.93
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Financial Difficulties Follow-Up 1
|
-1.73 Units on a scale
Standard Deviation 25.87
|
4.76 Units on a scale
Standard Deviation 39.84
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Financial Difficulties Follow-Up 2
|
-1.08 Units on a scale
Standard Deviation 22.56
|
-2.38 Units on a scale
Standard Deviation 28.59
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Fatigue Follow-Up 1
|
8.95 Units on a scale
Standard Deviation 23.78
|
15.66 Units on a scale
Standard Deviation 28.00
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Fatigue Follow-Up 2
|
4.84 Units on a scale
Standard Deviation 22.55
|
7.14 Units on a scale
Standard Deviation 21.85
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Nausea and Vomiting Follow-Up 1
|
2.81 Units on a scale
Standard Deviation 17.19
|
10.61 Units on a scale
Standard Deviation 25.48
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Nausea and Vomiting Follow-Up 2
|
0.00 Units on a scale
Standard Deviation 15.39
|
2.98 Units on a scale
Standard Deviation 18.73
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Pain Follow-Up 1
|
6.06 Units on a scale
Standard Deviation 31.17
|
6.82 Units on a scale
Standard Deviation 25.02
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Pain Follow-Up 2
|
5.38 Units on a scale
Standard Deviation 24.84
|
-1.79 Units on a scale
Standard Deviation 14.59
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Physical Functioning Follow-Up 1
|
-7.97 Units on a scale
Standard Deviation 20.49
|
-12.73 Units on a scale
Standard Deviation 21.47
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Physical Functioning Follow-Up 2
|
-3.66 Units on a scale
Standard Deviation 16.05
|
-7.14 Units on a scale
Standard Deviation 16.02
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Role Functioning Follow-Up 2
|
-7.80 Units on a scale
Standard Deviation 25.56
|
-8.33 Units on a scale
Standard Deviation 21.52
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Emotional Functioning Follow-Up 1
|
-5.09 Units on a scale
Standard Deviation 21.59
|
-15.48 Units on a scale
Standard Deviation 24.48
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Emotional Functioning Follow-Up 2
|
-0.94 Units on a scale
Standard Deviation 19.15
|
-5.36 Units on a scale
Standard Deviation 25.98
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Cognitive Functioning Follow-Up 1
|
-7.58 Units on a scale
Standard Deviation 16.79
|
-7.94 Units on a scale
Standard Deviation 17.17
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Cognitive Functioning Follow-Up 2
|
-3.49 Units on a scale
Standard Deviation 15.43
|
-1.19 Units on a scale
Standard Deviation 13.55
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Social Functioning Follow-Up 1
|
-8.66 Units on a scale
Standard Deviation 29.45
|
-18.25 Units on a scale
Standard Deviation 26.82
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Social Functioning Follow-Up 2
|
-1.61 Units on a scale
Standard Deviation 29.52
|
-4.17 Units on a scale
Standard Deviation 24.69
|
|
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Global Health Status Follow-Up 1
|
-8.23 Units on a scale
Standard Deviation 22.44
|
-10.71 Units on a scale
Standard Deviation 17.71
|
Adverse Events
Nivolumab
Serious events: 191 serious events
Other events: 255 other events
Deaths: 206 deaths
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Serious events: 37 serious events
Other events: 95 other events
Deaths: 88 deaths
Serious adverse events
| Measure |
Nivolumab
n=268 participants at risk
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=102 participants at risk
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
4/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Atrial flutter
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Cardiac failure
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Pericarditis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Sinus tachycardia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Eye disorders
Retinal detachment
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
5/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Ascites
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Colitis
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Constipation
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
4/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Haematemesis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Asthenia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Chest pain
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Fatigue
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Gait disturbance
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
General physical health deterioration
|
2.2%
6/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Infusion site extravasation
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Non-cardiac chest pain
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Pain
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Pelvic mass
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Pyrexia
|
1.9%
5/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Ulcer
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Immune system disorders
Hypersensitivity
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Bacterial infection
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Bronchitis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Bronchitis bacterial
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Cellulitis
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Clostridium difficile infection
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Cystitis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Device related infection
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Diverticulitis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Erysipelas
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Febrile infection
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Gastroenteritis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Herpes zoster
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Infection
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Localised infection
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Pneumonia
|
3.0%
8/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Sepsis
|
1.5%
4/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Urosepsis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Vascular device infection
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Wound infection
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Vascular access site thrombosis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Ejection fraction abnormal
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
General physical condition abnormal
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Hepatic enzyme increased
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Influenza B virus test positive
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Lipase increased
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Liver function test abnormal
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Liver function test increased
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
5/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
7/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
4/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.9%
5/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
32.1%
86/268 • From first dose to 100 days post last dose (Up to 96 months)
|
17.6%
18/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
3.0%
8/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.5%
4/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Aphasia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Autoimmune neuropathy
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Brain oedema
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Demyelination
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Dizziness
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Epilepsy
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Facial paresis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Headache
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Incoherent
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Monoplegia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Paraplegia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Seizure
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Status epilepticus
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
VIth nerve paralysis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Psychiatric disorders
Burnout syndrome
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Psychiatric disorders
Confusional state
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Renal and urinary disorders
Renal failure
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
5/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Embolism
|
0.75%
2/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Hypertension
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Hypotension
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Peripheral ischaemia
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Superior vena cava syndrome
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
Other adverse events
| Measure |
Nivolumab
n=268 participants at risk
Nivolumab 3 mg/kg IV over 60 minutes Q2W
|
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
n=102 participants at risk
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.3%
65/268 • From first dose to 100 days post last dose (Up to 96 months)
|
30.4%
31/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.5%
4/268 • From first dose to 100 days post last dose (Up to 96 months)
|
9.8%
10/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
23.5%
24/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
8/268 • From first dose to 100 days post last dose (Up to 96 months)
|
10.8%
11/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Endocrine disorders
Hypothyroidism
|
10.1%
27/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
18.7%
50/268 • From first dose to 100 days post last dose (Up to 96 months)
|
12.7%
13/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
21/268 • From first dose to 100 days post last dose (Up to 96 months)
|
5.9%
6/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Constipation
|
19.8%
53/268 • From first dose to 100 days post last dose (Up to 96 months)
|
22.5%
23/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.6%
90/268 • From first dose to 100 days post last dose (Up to 96 months)
|
17.6%
18/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
14/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
21/268 • From first dose to 100 days post last dose (Up to 96 months)
|
3.9%
4/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Nausea
|
34.0%
91/268 • From first dose to 100 days post last dose (Up to 96 months)
|
42.2%
43/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Gastrointestinal disorders
Vomiting
|
21.3%
57/268 • From first dose to 100 days post last dose (Up to 96 months)
|
23.5%
24/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Asthenia
|
13.1%
35/268 • From first dose to 100 days post last dose (Up to 96 months)
|
10.8%
11/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Chills
|
6.7%
18/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Fatigue
|
50.4%
135/268 • From first dose to 100 days post last dose (Up to 96 months)
|
51.0%
52/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Influenza like illness
|
7.5%
20/268 • From first dose to 100 days post last dose (Up to 96 months)
|
3.9%
4/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Oedema peripheral
|
16.4%
44/268 • From first dose to 100 days post last dose (Up to 96 months)
|
4.9%
5/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Pain
|
10.1%
27/268 • From first dose to 100 days post last dose (Up to 96 months)
|
3.9%
4/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
General disorders
Pyrexia
|
19.4%
52/268 • From first dose to 100 days post last dose (Up to 96 months)
|
9.8%
10/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
26/268 • From first dose to 100 days post last dose (Up to 96 months)
|
3.9%
4/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
25/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Infections and infestations
Urinary tract infection
|
9.0%
24/268 • From first dose to 100 days post last dose (Up to 96 months)
|
3.9%
4/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.1%
3/268 • From first dose to 100 days post last dose (Up to 96 months)
|
8.8%
9/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Alanine aminotransferase increased
|
10.8%
29/268 • From first dose to 100 days post last dose (Up to 96 months)
|
3.9%
4/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Aspartate aminotransferase increased
|
14.2%
38/268 • From first dose to 100 days post last dose (Up to 96 months)
|
5.9%
6/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
8.2%
22/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Blood creatinine increased
|
7.5%
20/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Neutrophil count decreased
|
0.37%
1/268 • From first dose to 100 days post last dose (Up to 96 months)
|
7.8%
8/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Platelet count decreased
|
4.1%
11/268 • From first dose to 100 days post last dose (Up to 96 months)
|
8.8%
9/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
Weight decreased
|
9.3%
25/268 • From first dose to 100 days post last dose (Up to 96 months)
|
7.8%
8/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Investigations
White blood cell count decreased
|
2.6%
7/268 • From first dose to 100 days post last dose (Up to 96 months)
|
8.8%
9/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.1%
54/268 • From first dose to 100 days post last dose (Up to 96 months)
|
20.6%
21/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.2%
14/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.2%
14/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.5%
20/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
15/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.00%
0/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
15/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.3%
25/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.4%
76/268 • From first dose to 100 days post last dose (Up to 96 months)
|
20.6%
21/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.5%
55/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
16/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.6%
31/268 • From first dose to 100 days post last dose (Up to 96 months)
|
9.8%
10/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
15/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
37/268 • From first dose to 100 days post last dose (Up to 96 months)
|
12.7%
13/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Dizziness
|
11.2%
30/268 • From first dose to 100 days post last dose (Up to 96 months)
|
4.9%
5/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Headache
|
17.5%
47/268 • From first dose to 100 days post last dose (Up to 96 months)
|
10.8%
11/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
3.7%
10/268 • From first dose to 100 days post last dose (Up to 96 months)
|
10.8%
11/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Nervous system disorders
Paraesthesia
|
4.9%
13/268 • From first dose to 100 days post last dose (Up to 96 months)
|
12.7%
13/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Psychiatric disorders
Anxiety
|
7.1%
19/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Psychiatric disorders
Depression
|
3.0%
8/268 • From first dose to 100 days post last dose (Up to 96 months)
|
5.9%
6/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Psychiatric disorders
Insomnia
|
12.7%
34/268 • From first dose to 100 days post last dose (Up to 96 months)
|
5.9%
6/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.2%
73/268 • From first dose to 100 days post last dose (Up to 96 months)
|
7.8%
8/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.4%
52/268 • From first dose to 100 days post last dose (Up to 96 months)
|
13.7%
14/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
8/268 • From first dose to 100 days post last dose (Up to 96 months)
|
29.4%
30/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.0%
24/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.9%
3/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.2%
73/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.3%
57/268 • From first dose to 100 days post last dose (Up to 96 months)
|
5.9%
6/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.2%
22/268 • From first dose to 100 days post last dose (Up to 96 months)
|
2.0%
2/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
11.6%
31/268 • From first dose to 100 days post last dose (Up to 96 months)
|
0.98%
1/102 • From first dose to 100 days post last dose (Up to 96 months)
|
|
Vascular disorders
Hypertension
|
7.8%
21/268 • From first dose to 100 days post last dose (Up to 96 months)
|
3.9%
4/102 • From first dose to 100 days post last dose (Up to 96 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