Trial Outcomes & Findings for Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (NCT NCT02785952)
NCT ID: NCT02785952
Last Updated: 2025-05-21
Results Overview
Duration from randomization to death due to any cause
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
275 participants
Primary outcome timeframe
From date of registration to maximum of 3 years or death
Results posted on
2025-05-21
Participant Flow
Of 275 enrolled patients, 252 were deemed eligible (125 randomized to nivolumab/ipilimumab and 127 to nivolumab).
Participant milestones
| Measure |
Arm I (Nivolumab, Ipilimumab)
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
127
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
125
|
127
|
Reasons for withdrawal
| Measure |
Arm I (Nivolumab, Ipilimumab)
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Adverse Event
|
31
|
19
|
|
Overall Study
Refusal unrelated to adverse events
|
10
|
5
|
|
Overall Study
Disease progression/relapse
|
61
|
89
|
|
Overall Study
Death
|
11
|
7
|
|
Overall Study
Other- not protocol specified
|
6
|
4
|
|
Overall Study
On protocol treatment
|
6
|
3
|
Baseline Characteristics
Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers
Baseline characteristics by cohort
| Measure |
Arm I (Nivolumab, Ipilimumab)
n=125 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Nivolumab)
n=127 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=99 Participants
|
68.1 years
n=107 Participants
|
67.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
102 participants
n=99 Participants
|
104 participants
n=107 Participants
|
206 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown race
|
4 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown ethnicity
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
No. of prior systemic therapies for stage IV or recurrent disease
0
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
No. of prior systemic therapies for stage IV or recurrent disease
1
|
73 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
No. of prior systemic therapies for stage IV or recurrent disease
2
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
No. of prior systemic therapies for stage IV or recurrent disease
≥3
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
No. of prior systemic therapies for stage IV or recurrent disease
Unknown
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Zubrod performance score
0
|
36 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Zubrod performance score
1
|
89 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
181 Participants
n=206 Participants
|
|
Weight loss in past 6 months
<5%
|
86 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
|
Weight loss in past 6 months
5% to <10%
|
25 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Weight loss in past 6 months
10% to <20%
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Weight loss in past 6 months
≥20%
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Smoking status
Current
|
48 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Smoking status
Former
|
75 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Smoking status
Never
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Brain metastases at baseline
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Liver metastases at baseline
|
23 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Prior radiation therapy
Localized radiation
|
36 participants
n=99 Participants
|
49 participants
n=107 Participants
|
85 participants
n=206 Participants
|
|
Prior radiation therapy
Radiation with curative intent
|
41 participants
n=99 Participants
|
45 participants
n=107 Participants
|
86 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From date of registration to maximum of 3 years or deathPopulation: Eligible and evaluable participants
Duration from randomization to death due to any cause
Outcome measures
| Measure |
Arm I (Nivolumab, Ipilimumab)
n=125 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Nivolumab)
n=127 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Survival
|
10 months
Interval 8.0 to 14.4
|
11 months
Interval 8.6 to 13.7
|
SECONDARY outcome
Timeframe: From date of registration to maximum of 3 years or deathPopulation: Eligible and evaluable participants
Duration from randomization to first occurrence of progression by RECIST 1.1, symptomatic deterioration, or death due to any cause. The IA-PFS for patients last known to be alive and free of progression or symptomatic deterioration was censored at the date of last disease assessment. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline as well as an absolute increase of at least 0.5 cm; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration
Outcome measures
| Measure |
Arm I (Nivolumab, Ipilimumab)
n=125 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Nivolumab)
n=127 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Investigator-assessed Progression-free Survival (IA-PFS)
|
3.8 months
Interval 2.7 to 4.4
|
2.9 months
Interval 1.8 to 4.0
|
SECONDARY outcome
Timeframe: From date of registration to maximum of 3 years or deathPopulation: Eligible and evaluable participants
Response was defined as the occurrence of a complete or partial response, confirmed or unconfirmed per RECIST 1.1 criteria. Response for patients not known to have a response was coded as nonresponse. Complete response: Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. Partial response: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
Outcome measures
| Measure |
Arm I (Nivolumab, Ipilimumab)
n=125 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Nivolumab)
n=127 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Objective Response Rate
|
18 percentage of participants
Interval 12.0 to 25.0
|
17 percentage of participants
Interval 10.0 to 23.0
|
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. CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for reporting SAEs.
Outcome measures
| Measure |
Arm I (Nivolumab, Ipilimumab)
n=124 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Nivolumab)
n=123 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
5 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increased
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
5 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
6 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrioventricular block complete
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Autoimmune disorder
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood bilirubin increased
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac arrest
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac troponin I increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chronic kidney disease
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
1 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Death NOS
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
3 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
5 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Enterocolitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erythroderma
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fall
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
11 Participants
|
7 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
General disorders and admin site conditions - Other
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Headache
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Heart failure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hepatic failure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hepatobiliary disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypercalcemia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperkalemia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperthyroidism
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoalbuminemia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
3 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
7 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
4 Participants
|
1 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
Insomnia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lipase increased
|
6 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
2 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
3 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Memory impairment
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myalgia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myocarditis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myositis
|
1 Participants
|
0 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
Pancreatitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Periorbital edema
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pleural effusion
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
9 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash maculo-papular
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Resp, thoracic and mediastinal disorders - Other
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory failure
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Serum amylase increased
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin and subcutaneous tissue disorders - Other
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin infection
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Treatment related secondary malignancy
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight gain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sore throat
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Stroke
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Supraventricular tachycardia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
1 Participants
|
1 Participants
|
Adverse Events
Nivolumab + Ipilimumab
Serious events: 78 serious events
Other events: 122 other events
Deaths: 92 deaths
Nivolumab
Serious events: 58 serious events
Other events: 123 other events
Deaths: 105 deaths
Serious adverse events
| Measure |
Nivolumab + Ipilimumab
n=124 participants at risk
Participants receive nivolumab on day 1 of each 14-day cycle and ipilimumab on day 1 of every third cycle beginning with cycle 1.
Nivolumab: Given IV Durvalumab: Given IV
|
Nivolumab
n=123 participants at risk
Participants receive nivolumab on day 1 of each 14-day cycle.
Nivolumab: Given IV.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Cardiac arrest
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Heart failure
|
2.4%
3/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Myocardial infarction
|
4.0%
5/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Myocarditis
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Sinus tachycardia
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Endocrine disorders
Hyperthyroidism
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Endocrine disorders
Hypothyroidism
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Eye disorders
Retinal vascular disorder
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Colitis
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
3/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
5/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Chills
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Death NOS
|
4.8%
6/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Edema limbs
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Fatigue
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Fever
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Flu like symptoms
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Hypothermia
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Localized edema
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Malaise
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Non-cardiac chest pain
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Pain
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Sudden death NOS
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Hepatobiliary disorders
Hepatobiliary disorders-Other
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Immune system disorders
Autoimmune disorder
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Bronchial infection
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Catheter related infection
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Device related infection
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Infections and infestations-Other
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Lung infection
|
10.5%
13/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.1%
10/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Mucosal infection
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Sepsis
|
4.0%
5/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Skin infection
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Urinary tract infection
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Injury, poisoning and procedural complications
Fall
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Alkaline phosphatase increased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
6/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Blood bilirubin increased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Cardiac troponin I increased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Ejection fraction decreased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Lipase increased
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Lymphocyte count decreased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Neutrophil count decreased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Platelet count decreased
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Serum amylase increased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Weight loss
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
White blood cell decreased
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.4%
3/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
3/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Dysarthria
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Edema cerebral
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Encephalopathy
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Lethargy
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Somnolence
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Stroke
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Syncope
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Confusion
|
4.8%
6/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Depression
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Psychosis
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Renal and urinary disorders
Renal colic
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.5%
18/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
10.6%
13/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
5/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
3/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
4.1%
5/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.1%
10/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
4.1%
5/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.00%
0/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Vascular disorders
Hypertension
|
1.6%
2/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
1.6%
2/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Vascular disorders
Hypotension
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
2.4%
3/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Vascular disorders
Thromboembolic event
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
0.81%
1/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
Other adverse events
| Measure |
Nivolumab + Ipilimumab
n=124 participants at risk
Participants receive nivolumab on day 1 of each 14-day cycle and ipilimumab on day 1 of every third cycle beginning with cycle 1.
Nivolumab: Given IV Durvalumab: Given IV
|
Nivolumab
n=123 participants at risk
Participants receive nivolumab on day 1 of each 14-day cycle.
Nivolumab: Given IV.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
46.8%
58/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
39.0%
48/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Cardiac disorders
Sinus tachycardia
|
8.9%
11/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
4.9%
6/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Endocrine disorders
Hyperthyroidism
|
11.3%
14/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.1%
10/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Endocrine disorders
Hypothyroidism
|
18.5%
23/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
14.6%
18/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Eye disorders
Blurred vision
|
7.3%
9/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
4.1%
5/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Eye disorders
Eye disorders-Other
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.1%
20/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Constipation
|
27.4%
34/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
23.6%
29/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Diarrhea
|
29.8%
37/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
34.1%
42/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Dry mouth
|
14.5%
18/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.9%
11/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
4.0%
5/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
4.9%
6/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Nausea
|
36.3%
45/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
35.8%
44/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Gastrointestinal disorders
Vomiting
|
17.7%
22/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
20.3%
25/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Chills
|
12.9%
16/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
11.4%
14/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Edema limbs
|
12.9%
16/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
14.6%
18/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Fatigue
|
55.6%
69/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
61.0%
75/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Fever
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
13.0%
16/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Flu like symptoms
|
0.81%
1/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Non-cardiac chest pain
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
14.6%
18/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
General disorders
Pain
|
18.5%
23/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
26.0%
32/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Infections and infestations-Other
|
4.8%
6/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Lung infection
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
10.6%
13/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Sinusitis
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Skin infection
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Upper respiratory infection
|
8.9%
11/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
9.8%
12/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
3/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
9.8%
12/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Alanine aminotransferase increased
|
20.2%
25/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.1%
10/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Alkaline phosphatase increased
|
23.4%
29/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
20.3%
25/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Aspartate aminotransferase increased
|
17.7%
22/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
10.6%
13/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Blood bilirubin increased
|
7.3%
9/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Creatinine increased
|
15.3%
19/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
13.8%
17/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Investigations-Other
|
15.3%
19/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
16.3%
20/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Lipase increased
|
8.9%
11/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.9%
11/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Lymphocyte count decreased
|
21.8%
27/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
20.3%
25/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Platelet count decreased
|
16.9%
21/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Serum amylase increased
|
8.1%
10/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
Weight loss
|
27.4%
34/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
22.0%
27/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Investigations
White blood cell decreased
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
38.7%
48/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
36.6%
45/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
13/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
10.6%
13/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.7%
12/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
9.8%
12/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.2%
25/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
26.0%
32/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.3%
9/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
11.4%
14/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.7%
48/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
39.0%
48/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.1%
15/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
13.0%
16/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.2%
35/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
17.1%
21/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
29.8%
37/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
21.1%
26/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.1%
46/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
35.0%
43/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
9.7%
12/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.1%
10/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
20/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.2%
4/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.3%
19/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
15.3%
19/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
13.8%
17/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.3%
14/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.7%
17/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
17.1%
21/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Dizziness
|
16.9%
21/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
17.1%
21/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Dysgeusia
|
4.0%
5/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.1%
10/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Headache
|
12.9%
16/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
15.4%
19/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.9%
11/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
10.6%
13/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Anxiety
|
12.1%
15/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
12.2%
15/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Confusion
|
7.3%
9/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
4.9%
6/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Depression
|
4.8%
6/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.1%
10/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Psychiatric disorders
Insomnia
|
9.7%
12/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
16.3%
20/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Renal and urinary disorders
Hematuria
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.7%
43/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
34.1%
42/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.1%
46/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
47.2%
58/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.8%
6/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
8.9%
11/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.5%
8/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
3.3%
4/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
6/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.7%
12/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
11.4%
14/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
7.3%
9/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
7/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.3%
9/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
9.8%
12/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.1%
15/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
9.8%
12/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
31/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
19.5%
24/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
31/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
14.6%
18/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
9.7%
12/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
7.3%
9/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
5.7%
7/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Vascular disorders
Hypertension
|
15.3%
19/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
9.8%
12/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
|
Vascular disorders
Hypotension
|
11.3%
14/124 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
6.5%
8/123 • Duration of treatment and follow up until death or 3 years post registration
CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for SAE reporting. All-Cause Mortality was assessed for all 252 eligible participants: 125 in the nivolumab/ipilimumab arm and 127 in the nivolumab arm. SAEs and other AEs were assessed for the 247 participants who received protocol therapy: 124 in the nivolumab/ipilimumab arm and 123 in the nivolumab arm.
|
Additional Information
Lung 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