Trial Outcomes & Findings for Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064) (NCT NCT01783938)
NCT ID: NCT01783938
Last Updated: 2021-08-13
Results Overview
The percentage of participants with treatment-related grade 3-5 adverse events (AEs) is defined as the number of participants who experienced at least 1 treatment related grade 3 - 5 adverse event (AE) per national cancer institute common terminology criteria for adverse events (NCI CTCAE v4.0, any preferred term) with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related = having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 3=Severe Gr 4=Potentially Life-threatening or disabling Gr 5=Death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
From Day 1 to up to Week 25
Results posted on
2021-08-13
Participant Flow
Of the 140 randomized,138 treated because 1 experienced adverse event unrelated to study drug and 1 no longer met study criteria.
Participant milestones
| Measure |
Nivolumab Followed by Ipilimumab
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
70
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
57
|
61
|
Reasons for withdrawal
| Measure |
Nivolumab Followed by Ipilimumab
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Overall Study
Disease Progression
|
18
|
41
|
|
Overall Study
Study Drug Toxicity
|
27
|
14
|
|
Overall Study
Adverse Event Unrelated to Study Drug
|
4
|
2
|
|
Overall Study
Participant Request to Discontinue Study Treatment
|
2
|
3
|
|
Overall Study
Participant Withdrew Consent
|
2
|
0
|
|
Overall Study
Maximum Clinical Benefit
|
1
|
0
|
|
Overall Study
Other Reasons
|
3
|
1
|
Baseline Characteristics
Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)
Baseline characteristics by cohort
| Measure |
Nivolumab Followed by Ipilimumab
n=68 Participants
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
n=70 Participants
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 14.08 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 15.17 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 14.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 participants
n=5 Participants
|
66 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to up to Week 25Population: All treated participants
The percentage of participants with treatment-related grade 3-5 adverse events (AEs) is defined as the number of participants who experienced at least 1 treatment related grade 3 - 5 adverse event (AE) per national cancer institute common terminology criteria for adverse events (NCI CTCAE v4.0, any preferred term) with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related = having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 3=Severe Gr 4=Potentially Life-threatening or disabling Gr 5=Death
Outcome measures
| Measure |
Nivolumab Followed by Ipilimumab
n=68 Participants
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
n=70 Participants
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Percentage of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) During the Induction Period (Period 1 and 2)
|
64.7 Percentage of participants
Interval 37.6 to 62.4
|
51.4 Percentage of participants
Interval 31.1 to 55.3
|
SECONDARY outcome
Timeframe: Week 25Population: All treated participants
Response rate is defined as the number of participants who have a complete response (CR) or partial response (PR) at Week 25 per modified RECIST 1.1 criteria, with confirmation on the scheduled scan at Week 33 (or any subsequent scan performed at least 4 weeks after the Week 25 scan), divided by the total number of treated participants. Results of the tumor assessment at Week 13 or any unscheduled tumor assessment obtained prior to Week 25, except for baseline/screening tumor assessment, were not considered in the assessment of response rate at Week 25.
Outcome measures
| Measure |
Nivolumab Followed by Ipilimumab
n=68 Participants
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
n=70 Participants
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Investigator-Assessed Response Rate at Week 25
|
54.7 Percentage of participants
Interval 40.0 to 68.4
|
30.4 Percentage of participants
Interval 17.7 to 45.8
|
SECONDARY outcome
Timeframe: From week 25 to up to date of disease progression or death (Up to 6 years)Population: All treated participants with confirmed response at week 25
Duration of response (DOR) is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. Median computed using Kaplan-Meier method.
Outcome measures
| Measure |
Nivolumab Followed by Ipilimumab
n=29 Participants
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
n=14 Participants
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Investigator-Assessed Duration of Response (DOR)
|
NA months
Interval 25.4 to
Median and upper limit not reached because of too few events to evaluate
|
57.66 months
Interval 13.67 to
Upper limit not reached because of too few events to evaluate
|
SECONDARY outcome
Timeframe: Week 13 and Week 25Population: All treated participants
Progression rate at a specific timepoint is defined as the number of participants who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of treated participants. As specified by modified RECIST 1.1, the evaluation of PD at Week 13 and Week 25 used the baseline tumor assessment as reference. A participant who died without a reported prior progression was considered to have progressed on the date of death. Deaths before or at Week 13 are counted as progression outcome. Confidence interval is based on the Clopper and Pearson method.
Outcome measures
| Measure |
Nivolumab Followed by Ipilimumab
n=68 Participants
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
n=70 Participants
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Investigator-Assessed Rate of Progression
Week 13
|
36.8 Percentage of participants
Interval 25.4 to 49.3
|
62.9 Percentage of participants
Interval 50.5 to 74.1
|
|
Investigator-Assessed Rate of Progression
Week 25
|
36.8 Percentage of participants
Interval 25.4 to 49.3
|
60.0 Percentage of participants
Interval 47.6 to 71.5
|
Adverse Events
Nivolumab Followed by Ipilimumab
Serious events: 59 serious events
Other events: 68 other events
Deaths: 35 deaths
Ipilimumab Followed by Nivolumab
Serious events: 57 serious events
Other events: 68 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
Nivolumab Followed by Ipilimumab
n=68 participants at risk
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
n=70 participants at risk
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Vascular disorders
Embolism
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Vascular disorders
Hypotension
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Angina pectoris
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Atrial fibrillation
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Cardiac failure
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Addison's disease
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Adrenal insufficiency
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Hypophysitis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Hypopituitarism
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Eye disorders
Macular oedema
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Eye disorders
Vision blurred
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Colitis
|
19.1%
13/68 • From first dose to 100 days post last dose (Up to 6 years)
|
21.4%
15/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Nausea
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Terminal ileitis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Asthenia
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Fatigue
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
14.3%
10/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Gait disturbance
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Malaise
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Oedema peripheral
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Pain
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Pyrexia
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Systemic inflammatory response syndrome
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Hepatobiliary disorders
Hepatic failure
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Hepatobiliary disorders
Hepatitis
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Immune system disorders
Autoimmune disorder
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Appendicitis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Bacterial infection
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Cytomegalovirus infection
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Diverticulitis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Encephalitis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Infected cyst
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Pneumonia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Sepsis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Sinusitis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Soft tissue infection
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Wound infection
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Hepatic enzyme increased
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Influenza A virus test positive
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Lipase increased
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
10.3%
7/68 • From first dose to 100 days post last dose (Up to 6 years)
|
31.4%
22/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Ataxia
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Brain oedema
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Headache
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Meningitis noninfective
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Myasthenia gravis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Syncope
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Psychiatric disorders
Confusional state
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Bladder spasm
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Renal tubular necrosis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Vascular disorders
Jugular vein thrombosis
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Vascular disorders
Thrombosis
|
0.00%
0/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
Other adverse events
| Measure |
Nivolumab Followed by Ipilimumab
n=68 participants at risk
Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 1 to 13 in Induction Period 1 followed by Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 13 to 25 in Induction Period 2.
|
Ipilimumab Followed by Nivolumab
n=70 participants at risk
Ipilimumab 3 mg/kg Q3W IV over 90 min for up to 4 doses during Weeks 1 to 13 in Induction Period 1 followed by Nivolumab 3 mg/kg Q2W IV over 60 min for up to 6 doses during Weeks 13 to 25 in Induction Period 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
36.8%
25/68 • From first dose to 100 days post last dose (Up to 6 years)
|
35.7%
25/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Cardiac disorders
Sinus tachycardia
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Adrenal insufficiency
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Hyperthyroidism
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Hypophysitis
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Endocrine disorders
Hypothyroidism
|
26.5%
18/68 • From first dose to 100 days post last dose (Up to 6 years)
|
28.6%
20/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Eye disorders
Diplopia
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Eye disorders
Dry eye
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Eye disorders
Photophobia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Eye disorders
Vision blurred
|
14.7%
10/68 • From first dose to 100 days post last dose (Up to 6 years)
|
14.3%
10/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
17/68 • From first dose to 100 days post last dose (Up to 6 years)
|
34.3%
24/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Colitis
|
10.3%
7/68 • From first dose to 100 days post last dose (Up to 6 years)
|
11.4%
8/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Constipation
|
39.7%
27/68 • From first dose to 100 days post last dose (Up to 6 years)
|
42.9%
30/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
64.7%
44/68 • From first dose to 100 days post last dose (Up to 6 years)
|
54.3%
38/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Flatulence
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Nausea
|
61.8%
42/68 • From first dose to 100 days post last dose (Up to 6 years)
|
57.1%
40/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Gastrointestinal disorders
Vomiting
|
32.4%
22/68 • From first dose to 100 days post last dose (Up to 6 years)
|
44.3%
31/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Asthenia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Chills
|
29.4%
20/68 • From first dose to 100 days post last dose (Up to 6 years)
|
21.4%
15/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Fatigue
|
82.4%
56/68 • From first dose to 100 days post last dose (Up to 6 years)
|
84.3%
59/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Gait disturbance
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Influenza like illness
|
17.6%
12/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Malaise
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Non-cardiac chest pain
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Oedema peripheral
|
25.0%
17/68 • From first dose to 100 days post last dose (Up to 6 years)
|
21.4%
15/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Pain
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
11.4%
8/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
General disorders
Pyrexia
|
44.1%
30/68 • From first dose to 100 days post last dose (Up to 6 years)
|
31.4%
22/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Candida infection
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Sinusitis
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Skin infection
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
17.6%
12/68 • From first dose to 100 days post last dose (Up to 6 years)
|
12.9%
9/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Infections and infestations
Urinary tract infection
|
13.2%
9/68 • From first dose to 100 days post last dose (Up to 6 years)
|
11.4%
8/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Injury, poisoning and procedural complications
Fall
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Alanine aminotransferase increased
|
44.1%
30/68 • From first dose to 100 days post last dose (Up to 6 years)
|
31.4%
22/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Amylase increased
|
29.4%
20/68 • From first dose to 100 days post last dose (Up to 6 years)
|
22.9%
16/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Aspartate aminotransferase increased
|
41.2%
28/68 • From first dose to 100 days post last dose (Up to 6 years)
|
31.4%
22/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
17/68 • From first dose to 100 days post last dose (Up to 6 years)
|
20.0%
14/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Blood bilirubin increased
|
14.7%
10/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Blood creatinine increased
|
4.4%
3/68 • From first dose to 100 days post last dose (Up to 6 years)
|
15.7%
11/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Blood urea increased
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Lipase increased
|
41.2%
28/68 • From first dose to 100 days post last dose (Up to 6 years)
|
32.9%
23/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Lymphocyte count decreased
|
10.3%
7/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Platelet count decreased
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
Weight decreased
|
22.1%
15/68 • From first dose to 100 days post last dose (Up to 6 years)
|
32.9%
23/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Investigations
White blood cell count decreased
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.6%
31/68 • From first dose to 100 days post last dose (Up to 6 years)
|
47.1%
33/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
17/68 • From first dose to 100 days post last dose (Up to 6 years)
|
28.6%
20/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
29.4%
20/68 • From first dose to 100 days post last dose (Up to 6 years)
|
14.3%
10/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
17.6%
12/68 • From first dose to 100 days post last dose (Up to 6 years)
|
14.3%
10/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.2%
9/68 • From first dose to 100 days post last dose (Up to 6 years)
|
22.9%
16/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.2%
9/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
35.3%
24/68 • From first dose to 100 days post last dose (Up to 6 years)
|
30.0%
21/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
48.5%
33/68 • From first dose to 100 days post last dose (Up to 6 years)
|
31.4%
22/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
17/68 • From first dose to 100 days post last dose (Up to 6 years)
|
22.9%
16/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
30.9%
21/68 • From first dose to 100 days post last dose (Up to 6 years)
|
24.3%
17/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.5%
16/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.1%
15/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Dizziness
|
26.5%
18/68 • From first dose to 100 days post last dose (Up to 6 years)
|
14.3%
10/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Dysgeusia
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Headache
|
45.6%
31/68 • From first dose to 100 days post last dose (Up to 6 years)
|
24.3%
17/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Nervous system disorders
Paraesthesia
|
14.7%
10/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Psychiatric disorders
Anxiety
|
13.2%
9/68 • From first dose to 100 days post last dose (Up to 6 years)
|
14.3%
10/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Psychiatric disorders
Confusional state
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Psychiatric disorders
Depression
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Psychiatric disorders
Insomnia
|
27.9%
19/68 • From first dose to 100 days post last dose (Up to 6 years)
|
18.6%
13/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Haematuria
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Nocturia
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Renal and urinary disorders
Urinary tract pain
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
0.00%
0/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.2%
28/68 • From first dose to 100 days post last dose (Up to 6 years)
|
38.6%
27/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.9%
19/68 • From first dose to 100 days post last dose (Up to 6 years)
|
22.9%
16/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.7%
10/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.3%
7/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.7%
10/68 • From first dose to 100 days post last dose (Up to 6 years)
|
14.3%
10/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
2.9%
2/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
10.3%
7/68 • From first dose to 100 days post last dose (Up to 6 years)
|
8.6%
6/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
10.3%
7/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.2%
11/68 • From first dose to 100 days post last dose (Up to 6 years)
|
12.9%
9/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.8%
6/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.4%
5/68 • From first dose to 100 days post last dose (Up to 6 years)
|
5.7%
4/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
47.1%
32/68 • From first dose to 100 days post last dose (Up to 6 years)
|
48.6%
34/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
47.1%
32/68 • From first dose to 100 days post last dose (Up to 6 years)
|
35.7%
25/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
17/68 • From first dose to 100 days post last dose (Up to 6 years)
|
21.4%
15/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.5%
1/68 • From first dose to 100 days post last dose (Up to 6 years)
|
10.0%
7/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.9%
4/68 • From first dose to 100 days post last dose (Up to 6 years)
|
1.4%
1/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
17.6%
12/68 • From first dose to 100 days post last dose (Up to 6 years)
|
18.6%
13/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Vascular disorders
Hot flush
|
2.9%
2/68 • From first dose to 100 days post last dose (Up to 6 years)
|
7.1%
5/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Vascular disorders
Hypertension
|
13.2%
9/68 • From first dose to 100 days post last dose (Up to 6 years)
|
4.3%
3/70 • From first dose to 100 days post last dose (Up to 6 years)
|
|
Vascular disorders
Hypotension
|
11.8%
8/68 • From first dose to 100 days post last dose (Up to 6 years)
|
11.4%
8/70 • From first dose to 100 days post last dose (Up to 6 years)
|
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