Trial Outcomes & Findings for Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma (NCT NCT01927419)
NCT ID: NCT01927419
Last Updated: 2022-03-18
Results Overview
Objective Response Rate is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), assessed by the investigator by using RECIST 1.1 criteria. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (\<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months)
Results posted on
2022-03-18
Participant Flow
142 participants were randomized, and 140 participants received treatment.
Participant milestones
| Measure |
Nivolumab + Ipilimumab
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Pre-Treatment Period
STARTED
|
95
|
47
|
|
Pre-Treatment Period
COMPLETED
|
94
|
46
|
|
Pre-Treatment Period
NOT COMPLETED
|
1
|
1
|
|
Treatment Period
STARTED
|
94
|
46
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
94
|
46
|
Reasons for withdrawal
| Measure |
Nivolumab + Ipilimumab
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Pre-Treatment Period
Adverse event unrelated to study drug
|
0
|
1
|
|
Pre-Treatment Period
Participants no longer meeting study criteria
|
1
|
0
|
|
Treatment Period
Disease progression
|
17
|
20
|
|
Treatment Period
Study drug toxicity
|
48
|
10
|
|
Treatment Period
Death
|
0
|
1
|
|
Treatment Period
Adverse event unrelated to study drug
|
6
|
3
|
|
Treatment Period
Participant request to discontinue
|
12
|
4
|
|
Treatment Period
Withdrawal by Subject
|
1
|
1
|
|
Treatment Period
Maximum Clinical Benefit
|
6
|
2
|
|
Treatment Period
Other reasons
|
3
|
4
|
|
Treatment Period
Not Reported
|
1
|
1
|
Baseline Characteristics
Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Nivolumab + Ipilimumab
n=95 Participants
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=47 Participants
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
64.5 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
63.7 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Age, Customized
Younger than 65 years
|
48 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Customized
65 years and older to younger than 75 years
|
35 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Customized
75 years and older
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months)Population: All randomized BRAF wild-type participants .
Objective Response Rate is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), assessed by the investigator by using RECIST 1.1 criteria. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (\<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=73 Participants
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=37 Participants
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants
|
60.3 Percentage of participants
Interval 48.1 to 71.5
|
10.8 Percentage of participants
Interval 3.0 to 25.4
|
SECONDARY outcome
Timeframe: From randomization to progression or death (up to approximately 88 months)Population: All randomized BRAF wild-type participants
PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, 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 died were censored on the date of their last evaluable tumor assessment. PFS values are based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=73 Participants
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=37 Participants
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Progression-Free Survival (PFS) - BRAF Wild-type (WT) Participants
|
58.41 Months
Interval 7.23 to
Upper Limit value could not be determined to insufficient number of events.
|
4.30 Months
Interval 2.76 to 5.32
|
SECONDARY outcome
Timeframe: From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months)Population: All randomized BRAF mutant participants
Objective Response Rate is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), assessed by the investigator by using RECIST 1.1 criteria. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (\<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=22 Participants
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=10 Participants
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Objective Response Rate (ORR) - BRAF Mutant Participants
|
54.5 Percentage of participants
Interval 32.2 to 75.6
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
SECONDARY outcome
Timeframe: From randomization to progression or death (up to approximately 88 months)Population: All randomized BRAF mutant participants
PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, 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 died were censored on the date of their last evaluable tumor assessment. PFS values are based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=22 Participants
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=10 Participants
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Progression-Free Survival (PFS) - BRAF Mutant Participants
|
8.61 Months
Interval 2.79 to
Upper Limit value could not be determined to insufficient number of events.
|
2.73 Months
Interval 0.99 to 5.42
|
SECONDARY outcome
Timeframe: From Baseline (prior to start of study treatment) to Week 25 after first dosePopulation: All randomized participants with available measurements at baseline and week 25
The EORTC QLQ-C30 version 3 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool, and it comprises 6 functional subscales (physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as 9 symptom subscales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for each subscale range from 0 to 100. For the 6 functional subscales, a higher score represents a better level of functioning/health status. For the 9 symptom subscales, a lower score represents a better outcome (low level of symptomatology). Scores for the 15 subscales are presented individually.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=22 Participants
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=13 Participants
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Physical Functioning
|
2.12 Score on a scale
Standard Deviation 17.625
|
1.03 Score on a scale
Standard Deviation 9.367
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Role Functioning
|
-1.52 Score on a scale
Standard Deviation 22.950
|
5.13 Score on a scale
Standard Deviation 21.926
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Emotional Functioning
|
8.33 Score on a scale
Standard Deviation 10.603
|
10.26 Score on a scale
Standard Deviation 17.063
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Cognitive Functioning
|
-1.52 Score on a scale
Standard Deviation 15.352
|
-2.56 Score on a scale
Standard Deviation 11.479
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Social Functioning
|
2.27 Score on a scale
Standard Deviation 22.593
|
0.00 Score on a scale
Standard Deviation 16.667
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Global Health Status
|
3.79 Score on a scale
Standard Deviation 11.422
|
-0.64 Score on a scale
Standard Deviation 29.357
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Fatigue
|
-3.54 Score on a scale
Standard Deviation 21.520
|
-0.85 Score on a scale
Standard Deviation 17.836
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Nausea and Vomiting
|
-3.03 Score on a scale
Standard Deviation 12.211
|
-2.56 Score on a scale
Standard Deviation 6.259
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Pain
|
-2.27 Score on a scale
Standard Deviation 12.905
|
-8.97 Score on a scale
Standard Deviation 21.099
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Dyspnea
|
-9.09 Score on a scale
Standard Deviation 23.417
|
-7.69 Score on a scale
Standard Deviation 27.735
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Insomnia
|
-12.12 Score on a scale
Standard Deviation 31.782
|
-12.82 Score on a scale
Standard Deviation 16.879
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Appetite Loss
|
-13.64 Score on a scale
Standard Deviation 30.271
|
-2.56 Score on a scale
Standard Deviation 16.452
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Constipation
|
-3.03 Score on a scale
Standard Deviation 20.339
|
0.00 Score on a scale
Standard Deviation 13.608
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Diarrhea
|
-3.03 Score on a scale
Standard Deviation 14.213
|
5.13 Score on a scale
Standard Deviation 12.518
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
Financial Difficulties
|
-3.03 Score on a scale
Standard Deviation 22.792
|
-2.78 Score on a scale
Standard Deviation 22.285
|
Adverse Events
Nivolumab + Ipilimumab
Serious events: 69 serious events
Other events: 90 other events
Deaths: 44 deaths
Ipilimumab
Serious events: 27 serious events
Other events: 45 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Nivolumab + Ipilimumab
n=94 participants at risk
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=46 participants at risk
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Blood and lymphatic system disorders
Haemolysis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Myocardial infarction
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Adrenal insufficiency
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Autoimmune thyroiditis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Endocrine disorder
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Hypophysitis
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Hypopituitarism
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Autoimmune colitis
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Colitis
|
13.8%
13/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Constipation
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
10/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Enterocolitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Oesophageal pain
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Pancreatitis
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Chills
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Generalised oedema
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Non-cardiac chest pain
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Pain
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Pyrexia
|
6.4%
6/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Hepatobiliary disorders
Hepatitis
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Hepatobiliary disorders
Hepatocellular injury
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Abdominal abscess
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Abscess
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Cellulitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Diverticulitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Encephalitis
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Enterococcal bacteraemia
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Epididymitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Necrotising fasciitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Oral candidiasis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Periorbital cellulitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Pneumonia
|
4.3%
4/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Sepsis
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Septic shock
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Amylase increased
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Blood creatinine increased
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Lipase increased
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Transaminases increased
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
10.6%
10/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
17.4%
8/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Dizziness
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Embolic stroke
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Guillain-Barre syndrome
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Meningoradiculitis
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Neuralgia
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Seizure
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Syncope
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Tremor
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.4%
7/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Embolism
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Hypertension
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Hypotension
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
Other adverse events
| Measure |
Nivolumab + Ipilimumab
n=94 participants at risk
Participants received 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
Ipilimumab
n=46 participants at risk
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.3%
4/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
21.3%
20/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
26.1%
12/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Colitis
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Blood and lymphatic system disorders
Anaemia
|
25.5%
24/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
32.6%
15/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Atrial fibrillation
|
6.4%
6/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
4/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Cardiac disorders
Tachycardia
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Adrenal insufficiency
|
7.4%
7/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Hypophysitis
|
10.6%
10/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Endocrine disorders
Hypothyroidism
|
19.1%
18/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
15.2%
7/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Eye disorders
Vision blurred
|
16.0%
15/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Constipation
|
34.0%
32/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
30.4%
14/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
57.4%
54/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
52.2%
24/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Dry mouth
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
13.0%
6/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
7/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
4/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
42.6%
40/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
54.3%
25/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Gastrointestinal disorders
Vomiting
|
30.9%
29/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
23.9%
11/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Asthenia
|
18.1%
17/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
23.9%
11/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Chills
|
22.3%
21/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
17.4%
8/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Fatigue
|
60.6%
57/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
73.9%
34/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Influenza like illness
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
13.0%
6/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Malaise
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Mucosal inflammation
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Non-cardiac chest pain
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Oedema peripheral
|
27.7%
26/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
21.7%
10/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Pain
|
14.9%
14/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
21.7%
10/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Peripheral swelling
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
General disorders
Pyrexia
|
34.0%
32/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
37.0%
17/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Pneumonia
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
7/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Infections and infestations
Urinary tract infection
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Alanine aminotransferase increased
|
31.9%
30/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
15.2%
7/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Amylase increased
|
14.9%
14/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
33.0%
31/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
15.2%
7/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
13.8%
13/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
15.2%
7/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Blood bilirubin increased
|
12.8%
12/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Blood creatinine increased
|
10.6%
10/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
7.4%
7/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Blood thyroid stimulating hormone increased
|
8.5%
8/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Lipase increased
|
23.4%
22/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
13.0%
6/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Platelet count decreased
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Weight decreased
|
17.0%
16/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Investigations
Weight increased
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.7%
26/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
37.0%
17/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
23.4%
22/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.8%
13/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.5%
8/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.7%
11/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
13.0%
6/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.0%
15/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.7%
11/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
23.4%
22/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
13.0%
6/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.7%
26/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
23.9%
11/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.2%
19/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
15.2%
7/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.4%
6/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.8%
12/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.9%
14/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
28.3%
13/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.6%
10/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
19.6%
9/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Dizziness
|
18.1%
17/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Dysgeusia
|
6.4%
6/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Headache
|
37.2%
35/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
23.9%
11/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Paraesthesia
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
4/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Nervous system disorders
Taste disorder
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Psychiatric disorders
Anxiety
|
7.4%
7/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Psychiatric disorders
Depression
|
4.3%
4/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Psychiatric disorders
Insomnia
|
21.3%
20/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
23.9%
11/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.9%
30/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
43.5%
20/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.4%
7/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.8%
28/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
30.4%
14/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
4.3%
2/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
9/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.6%
10/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.5%
8/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
47/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
37.0%
17/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
47.9%
45/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
37.0%
17/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.1%
2/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.0%
16/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
17.4%
8/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.2%
3/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
0.00%
0/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
11.7%
11/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Flushing
|
5.3%
5/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
2.2%
1/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Hot flush
|
1.1%
1/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
6.5%
3/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Hypertension
|
12.8%
12/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
8.7%
4/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
|
Vascular disorders
Hypotension
|
11.7%
11/94 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
10.9%
5/46 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 90 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 86 months).
All treated participants
|
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