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NCT02388906 · OUTCOME

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma · Source last updated 2025-04-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: reported after first dose and within 30 days of last dose of the study therapy

What was measured

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

Analysis population: Participants with a CTC graded Laboratory Result for the given parameter from both Baseline and On-treatment

Groups in this outcome

Nivolumab 3 mg/kg

Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24

Ipilimumab 10 mg/kg

Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	452
Ipilimumab 10 mg/kg	453

Reported measurements

Heamoglobin (grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	114	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	148	Not reported	Not reported	Not reported	Not reported

Heamoglobin (Grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	2	Not reported	Not reported	Not reported	Not reported

Platelet count (grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	27	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	25	Not reported	Not reported	Not reported	Not reported

Platelet count ( grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	1	Not reported	Not reported	Not reported	Not reported

Leukocytes (grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	62	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	12	Not reported	Not reported	Not reported	Not reported

Leukocytes (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	1	Not reported	Not reported	Not reported	Not reported

Lymphocytes (grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	118	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	54	Not reported	Not reported	Not reported	Not reported

Lymphocytes (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	4	Not reported	Not reported	Not reported	Not reported

Absolute Neutrophil count (Grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	56	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	26	Not reported	Not reported	Not reported	Not reported

Absolute Neutrophil count (Grade3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	2	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase (grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	441
Ipilimumab 10 mg/kg	437

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	35	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	69	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase (Grade3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	441
Ipilimumab 10 mg/kg	437

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	3	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase (grade 1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	445
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	105	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	144	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase(grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	445
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	6	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	39	Not reported	Not reported	Not reported	Not reported

Alkaline Aminotransferase (grade 1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	443

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	113	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	176	Not reported	Not reported	Not reported	Not reported

Alkaline Aminotransferase(grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	447
Ipilimumab 10 mg/kg	443

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	8	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	52	Not reported	Not reported	Not reported	Not reported

Total Bilirubin (grade 1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	33	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	43	Not reported	Not reported	Not reported	Not reported

Total Bilirubin (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	5	Not reported	Not reported	Not reported	Not reported

Creatinine ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	55	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	56	Not reported	Not reported	Not reported	Not reported

Creatinine (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	440

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Total Amylase ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	400
Ipilimumab 10 mg/kg	392

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	68	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	52	Not reported	Not reported	Not reported	Not reported

Total Amylase (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	400
Ipilimumab 10 mg/kg	392

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	13	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	12	Not reported	Not reported	Not reported	Not reported

Total Lipase ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	438
Ipilimumab 10 mg/kg	427

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	109	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	100	Not reported	Not reported	Not reported	Not reported

Total Lipase (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	438
Ipilimumab 10 mg/kg	427

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	31	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	38	Not reported	Not reported	Not reported	Not reported

Hypernatremia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	438

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	35	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	20	Not reported	Not reported	Not reported	Not reported

Hypernatremia (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	438

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	438

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	72	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	96	Not reported	Not reported	Not reported	Not reported

Hyponatremia (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	446
Ipilimumab 10 mg/kg	438

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	5	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	14	Not reported	Not reported	Not reported	Not reported

Hyperkalemia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	445
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	55	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	39	Not reported	Not reported	Not reported	Not reported

Hyperkalemia (grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	445
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	2	Not reported	Not reported	Not reported	Not reported

Hypokalemia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	445
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	37	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	45	Not reported	Not reported	Not reported	Not reported

Hypokalemia(grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	445
Ipilimumab 10 mg/kg	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	5	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	9	Not reported	Not reported	Not reported	Not reported

Hypercalcemia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	434
Ipilimumab 10 mg/kg	422

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	14	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	18	Not reported	Not reported	Not reported	Not reported

Hypercalcemia(grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	434
Ipilimumab 10 mg/kg	422

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Hypocalcemia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	434
Ipilimumab 10 mg/kg	422

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	46	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	73	Not reported	Not reported	Not reported	Not reported

Hypocalcemia(grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	434
Ipilimumab 10 mg/kg	422

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	3	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	2	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	441
Ipilimumab 10 mg/kg	435

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	20	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	7	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia(grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	441
Ipilimumab 10 mg/kg	435

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	1	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia ( grade1-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	441
Ipilimumab 10 mg/kg	435

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	39	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	32	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia(grade 3-4)

Analysis denominator · Participants

Group	Source count
Nivolumab 3 mg/kg	441
Ipilimumab 10 mg/kg	435

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab 3 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Ipilimumab 10 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
114
group Id
OG001
value
148
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
440
units
Participants
title
Heamoglobin (grade1-4)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
440
units
Participants
title
Heamoglobin (Grade 3-4)
categories
measurements
group Id
OG000
value
27
group Id
OG001
value
25
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
440
units
Participants
title
Platelet count (grade1-4)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
440
units
Participants
title
Platelet count ( grade 3-4)
categories
measurements
group Id
OG000
value
62
group Id
OG001
value
12
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
440
units
Participants
title
Leukocytes (grade1-4)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
440
units
Participants
title
Leukocytes (grade 3-4)
categories
measurements
group Id
OG000
value
118
group Id
OG001
value
54
denoms
counts
group Id
OG000
value
446
group Id
OG001
value
439
units
Participants
title
Lymphocytes (grade1-4)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
446
group Id
OG001
value
439
units
Participants
title
Lymphocytes (grade 3-4)
categories
measurements
group Id
OG000
value
56
group Id
OG001
value
26
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
439
units
Participants
title
Absolute Neutrophil count (Grade1-4)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
447
group Id
OG001
value
439
units
Participants
title
Absolute Neutrophil count (Grade3-4)
categories
measurements
group Id
OG000
value
35
group Id
OG001
value
69
denoms
counts
group Id
OG000
value
441
group Id
OG001
value
437
units
Participants
title
Alkaline Phosphatase (grade1-4)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
441
group Id
OG001
value
437
units
Participants
title
Alkaline Phosphatase (Grade3-4)

denoms

counts
group Id
OG000
value
452
group Id
OG001
value
453
units
Participants

description

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

groups

description
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
id
OG000
title
Nivolumab 3 mg/kg
description
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
id
OG001
title
Ipilimumab 10 mg/kg

param Type

NUMBER

population Description

Participants with a CTC graded Laboratory Result for the given parameter from both Baseline and On-treatment

reporting Status

POSTED

time Frame

reported after first dose and within 30 days of last dose of the study therapy

title

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice