Trial Outcomes & Findings for Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma (NCT NCT03033576)
NCT ID: NCT03033576
Last Updated: 2025-01-13
Results Overview
Progression-free survival (PFS) is defined as the time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact. Progression is defined as either 20% increase in the sum of diameters of target measurable lesions, unequivocal progression of non-measurable disease in the opinion of the treating physician, appearance of any new lesion, or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Results posted on
2025-01-13
Participant Flow
A total of 94 participants were assessed for eligibility; 24 to the Ipilimumab arm and 70 to the Nivolumab + Ipilimumab arm. Two participants were deemed ineligible, leaving 92 eligible and analyzable participants.
Participant milestones
| Measure |
Ipilimumab
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab 3mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab 1 mg/kg IV over 30 minutes and ipilimumab 3 mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab 480 mg IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
70
|
|
Overall Study
Eligible
|
23
|
69
|
|
Overall Study
Received Protocol-directed Therapy
|
23
|
68
|
|
Overall Study
COMPLETED
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
70
|
Reasons for withdrawal
| Measure |
Ipilimumab
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab 3mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab 1 mg/kg IV over 30 minutes and ipilimumab 3 mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab 480 mg IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Ineligible
|
1
|
1
|
|
Overall Study
Adverse Event
|
4
|
20
|
|
Overall Study
Progression/relapse
|
9
|
36
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Patient refusal
|
1
|
6
|
|
Overall Study
Other, unspecified reasons
|
0
|
4
|
|
Overall Study
Currently on protocol therapy
|
0
|
2
|
Baseline Characteristics
Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Ipilimumab
n=23 Participants
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=69 Participants
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Continuous
|
69 years
n=99 Participants
|
64 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Zubrod Performance Status Score
0
|
15 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Zubrod Performance Status Score
1
|
6 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Zubrod Performance Status Score
2
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
LDH
Elevated
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
LDH
Normal
|
5 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
LDH
LDH Not Done
|
12 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
AJCC Melanoma Classification
Stage III
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
AJCC Melanoma Classification
Stage IV
|
17 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Prior Adjuvant Therapy
No prior adjuvant therapy
|
17 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Prior Adjuvant Therapy
Adjuvant PD-1
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Prior Adjuvant Therapy
Adjuvant BRAF/MEK
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior Adjuvant Therapy
Other Adjuvant Therapy
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Prior Metastatic Therapy
Adjuvant Therapy Only
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Prior Metastatic Therapy
Anti-PD-1 only
|
20 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Prior Metastatic Therapy
BRAF/MEK followed by PD-1
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior Metastatic Therapy
Other anti-PD-1 combination
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Duration of prior anti-PD1/PD-L1 Therapy
< 6 Months
|
15 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Duration of prior anti-PD1/PD-L1 Therapy
>= 6 Months
|
8 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 yearsPopulation: Only eligible participants were analyzed for PFS.
Progression-free survival (PFS) is defined as the time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact. Progression is defined as either 20% increase in the sum of diameters of target measurable lesions, unequivocal progression of non-measurable disease in the opinion of the treating physician, appearance of any new lesion, or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Outcome measures
| Measure |
Ipilimumab
n=23 Participants
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=69 Participants
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Overall
All participants on the combination Nivolumab + Ipilimumab arm that were had biopsies available at baseline and four weeks after the start of protocol therapy.
|
|---|---|---|---|
|
Progression Free Survival
|
2.7 months
Interval 2.5 to 2.9
|
3.1 months
Interval 2.8 to 5.3
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: There were 83 total participants with biopsies available; 76 with a baseline biopsy and 56 with a biopsy from 28 days after start of protocol therapy. This resulted in a total of 40 paired biopsies on both arms after excluding samples that could not be analyzed because of absence of tumor due or insufficient tumor cells. Our analysis population for this outcome measure includes the 29 participants on the combination Nivolumab + Ipilimumab arm that had an analyzable paired biopsy.
Will estimate the quantitative change in CD8+ expression from baseline to day 28 on-study between patients who eventually respond and patients who do not respond in the Nivolumab + Ipilimumab arm.
Outcome measures
| Measure |
Ipilimumab
n=12 Participants
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=17 Participants
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Overall
n=29 Participants
All participants on the combination Nivolumab + Ipilimumab arm that were had biopsies available at baseline and four weeks after the start of protocol therapy.
|
|---|---|---|---|
|
Change in CD8+ Expression
|
0.4291 log10[cells per mm^2]
Standard Deviation 0.821187
|
0.2585 log10[cells per mm^2]
Standard Deviation 0.550321
|
0.3291 log10[cells per mm^2]
Standard Deviation 0.667305
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible participants were considered analyzable for this endpoint.
The overall objective response rate is defined as percentage of participants that achieved confirmed and unconfirmed, complete and partial responses. Complete response is defined as complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Partial response applies only to patients with at least one measurable lesion and is defined as \>= 30% decrease of the sum of diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions.
Outcome measures
| Measure |
Ipilimumab
n=23 Participants
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=69 Participants
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Overall
All participants on the combination Nivolumab + Ipilimumab arm that were had biopsies available at baseline and four weeks after the start of protocol therapy.
|
|---|---|---|---|
|
Overall Objective Response Rate
|
9 percentage of participants
Interval 2.0 to 25.0
|
28 percentage of participants
Interval 19.0 to 38.0
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible participants were included in the overall survival analysis.
Overall survival is defined as the time from randomization to the date of death from any cause.
Outcome measures
| Measure |
Ipilimumab
n=23 Participants
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=69 Participants
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Overall
All participants on the combination Nivolumab + Ipilimumab arm that were had biopsies available at baseline and four weeks after the start of protocol therapy.
|
|---|---|---|---|
|
Overall Survival
|
14.5 months
Interval 8.1 to
There was insufficient follow-up data to estimate an upper limit.
|
22.1 months
Interval 15.4 to 32.4
|
—
|
SECONDARY outcome
Timeframe: Duration of treatment and follow-up until death or 3 years post registrationPopulation: Participants who received at least one dose of protocol treatment
Only adverse events that are possibly, probably or definitely related to study drug are reported. Adverse Events (AEs) are reported by CTCAE Version 4.0.
Outcome measures
| Measure |
Ipilimumab
n=23 Participants
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=68 Participants
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Overall
All participants on the combination Nivolumab + Ipilimumab arm that were had biopsies available at baseline and four weeks after the start of protocol therapy.
|
|---|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
2 Participants
|
5 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
2 Participants
|
5 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrial fibrillation
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colonic perforation
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
3 Participants
|
9 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Enterocolitis
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypernatremia
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypocalcemia
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypothyroidism
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash maculo-papular
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adrenal insufficiency
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increased
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Autoimmune disorder
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood bilirubin increased
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Disseminated intravascular coagulation
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Endocrine disorders - Other, specify
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Metabolism and nutrition disorders - Other, specify
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Uveitis
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
0 Participants
|
3 Participants
|
—
|
Adverse Events
Ipilimumab
Serious events: 10 serious events
Other events: 23 other events
Deaths: 14 deaths
Nivolumab + Ipilimumab
Serious events: 38 serious events
Other events: 66 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Ipilimumab
n=23 participants at risk
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=68 participants at risk
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
11.8%
8/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Cardiac disorders
Heart failure
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Endocrine disorders
Adrenal insufficiency
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
4.4%
3/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Endocrine disorders
Endocrine disorders-Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
4.4%
3/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Colonic perforation
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
0.00%
0/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Chills
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Edema limbs
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Fatigue
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Fever
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
4.4%
3/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Flu like symptoms
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Infections and infestations-Other
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
4.4%
3/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Lung infection
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Sepsis
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Skin infection
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
4.4%
3/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Blood bilirubin increased
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
0.00%
0/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Creatinine increased
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
GGT increased
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Platelet count decreased
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
White blood cell decreased
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Depressed level of consciousness
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
0.00%
0/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Ischemia cerebrovascular
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
0.00%
0/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Seizure
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
4.4%
3/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
Other adverse events
| Measure |
Ipilimumab
n=23 participants at risk
Active Comparator: Arm I (ipilimumab)
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Nivolumab + Ipilimumab
n=68 participants at risk
Experimental: Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
26.1%
6/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
32.4%
22/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
10.3%
7/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Endocrine disorders
Adrenal insufficiency
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Endocrine disorders
Endocrine disorders-Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Endocrine disorders
Hypothyroidism
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Eye disorders
Blurred vision
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
13.2%
9/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Constipation
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
19.1%
13/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Diarrhea
|
39.1%
9/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
35.3%
24/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Mucositis oral
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
33.8%
23/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
5/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
14.7%
10/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Chills
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Edema limbs
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
11.8%
8/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Fatigue
|
56.5%
13/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
51.5%
35/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Fever
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
17.6%
12/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Flu like symptoms
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Non-cardiac chest pain
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
General disorders
Pain
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
14.7%
10/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Immune system disorders
Autoimmune disorder
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
0.00%
0/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Infections and infestations
Urinary tract infection
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Alanine aminotransferase increased
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
29.4%
20/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Alkaline phosphatase increased
|
26.1%
6/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
16.2%
11/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Aspartate aminotransferase increased
|
21.7%
5/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
32.4%
22/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
11.8%
8/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Creatinine increased
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
13.2%
9/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Investigations-Other
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
11.8%
8/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Lymphocyte count decreased
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
16.2%
11/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Platelet count decreased
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
Weight loss
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
13.2%
9/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Investigations
White blood cell decreased
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Anorexia
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
32.4%
22/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.4%
7/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
13.2%
9/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
2.9%
2/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
34.8%
8/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
23.5%
16/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
11.8%
8/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.4%
7/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
23.5%
16/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
10.3%
7/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
13.2%
9/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
11.8%
8/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
20.6%
14/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
17.6%
12/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Dysgeusia
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Headache
|
26.1%
6/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
27.9%
19/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
4.4%
3/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Psychiatric disorders
Depression
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
1.5%
1/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
3/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
22.1%
15/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.7%
5/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
17.6%
12/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
8.8%
6/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.7%
5/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
41.2%
28/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
7.4%
5/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.7%
5/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
36.8%
25/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
17.6%
12/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Vascular disorders
Hot flashes
|
4.3%
1/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
5.9%
4/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Vascular disorders
Hypertension
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
17.6%
12/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
|
Vascular disorders
Hypotension
|
8.7%
2/23 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
14.7%
10/68 • Duration of treatment and follow-up until death or 3 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only eligible participants who received protocol treatment were evaluated for adverse events (91 total; 23 on the ipilimumab arm; 68 on the nivolumab + ipilimumab arm), whereas all eligible participants were evaluated for all-cause mortality (92 total; 23 on the ipilimumab arm; 69 on the nivolumab + ipilimumab arm).
|
Additional Information
Melanoma Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60