NCT00094653 · OUTCOME

Percentage of Participants With Immune-Related Adverse Events (irAEs)

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma · Source last updated 2011-07-11

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).

What was measured

An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of "Other irAEs" includes blood, eye, immune, infections, renal, and respiratory systems.

Analysis population: All subjects who received at least 1 dose or any partial dose of study medication.

Groups in this outcome

Ipilimumab Plus gp100

Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

Ipilimumab Monotherapy

Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

gp100

Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

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
Ipilimumab Plus gp100	380
Ipilimumab Monotherapy	131
gp100	132

Reported measurements

Any On-Study irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	58.2	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	61.1	Not reported	Not reported	Not reported	Not reported
gp100	31.8	Not reported	Not reported	Not reported	Not reported

On-Study Severe irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	11.3	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	15.3	Not reported	Not reported	Not reported	Not reported
gp100	3.0	Not reported	Not reported	Not reported	Not reported

On-Study Serious irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	10.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	13.0	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

On-Study irAEs Leading to Discontinuation

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	5.8	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	8.4	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Death Due to irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.3	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	1.5	Not reported	Not reported	Not reported	Not reported
gp100	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal irAEs (any grade)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	32.1	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	29.0	Not reported	Not reported	Not reported	Not reported
gp100	14.4	Not reported	Not reported	Not reported	Not reported

Severe (>= Grade 3) Gastrointestinal irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	6.3	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	7.6	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Liver irAEs (any grade)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	2.1	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	3.8	Not reported	Not reported	Not reported	Not reported
gp100	4.5	Not reported	Not reported	Not reported	Not reported

Severe (>= Grade 3) Liver irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.1	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	0.8	Not reported	Not reported	Not reported	Not reported
gp100	2.3	Not reported	Not reported	Not reported	Not reported

Endocrine irAEs (any grade)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	3.9	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	7.6	Not reported	Not reported	Not reported	Not reported
gp100	1.5	Not reported	Not reported	Not reported	Not reported

Severe (>= Grade 3) Endocrine irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.1	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	3.8	Not reported	Not reported	Not reported	Not reported
gp100	0	Not reported	Not reported	Not reported	Not reported

Skin irAEs (any grade)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	40.0	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	43.5	Not reported	Not reported	Not reported	Not reported
gp100	16.7	Not reported	Not reported	Not reported	Not reported

Severe (>= Grade 3) Skin irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	2.4	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	1.5	Not reported	Not reported	Not reported	Not reported
gp100	0	Not reported	Not reported	Not reported	Not reported

Neurological irAEs (any grade)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	0.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	0	Not reported	Not reported	Not reported	Not reported
gp100	0	Not reported	Not reported	Not reported	Not reported

Severe (>= Grade 3) Neurological irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	0.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	0	Not reported	Not reported	Not reported	Not reported
gp100	0	Not reported	Not reported	Not reported	Not reported

Other irAEs (any grade)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	3.2	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	4.6	Not reported	Not reported	Not reported	Not reported
gp100	2.3	Not reported	Not reported	Not reported	Not reported

Severe (>= Grade 3) Other irAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.6	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	2.3	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
58.2
group Id
OG001
value
61.1
group Id
OG002
value
31.8
title
Any On-Study irAEs
categories
measurements
group Id
OG000
value
11.3
group Id
OG001
value
15.3
group Id
OG002
value
3.0
title
On-Study Severe irAEs
categories
measurements
group Id
OG000
value
10.5
group Id
OG001
value
13.0
group Id
OG002
value
0.8
title
On-Study Serious irAEs
categories
measurements
group Id
OG000
value
5.8
group Id
OG001
value
8.4
group Id
OG002
value
0.8
title
On-Study irAEs Leading to Discontinuation
categories
measurements
group Id
OG000
value
1.3
group Id
OG001
value
1.5
group Id
OG002
value
0
title
Death Due to irAEs
categories
measurements
group Id
OG000
value
32.1
group Id
OG001
value
29.0
group Id
OG002
value
14.4
title
Gastrointestinal irAEs (any grade)
categories
measurements
group Id
OG000
value
6.3
group Id
OG001
value
7.6
group Id
OG002
value
0.8
title
Severe (>= Grade 3) Gastrointestinal irAEs
categories
measurements
group Id
OG000
value
2.1
group Id
OG001
value
3.8
group Id
OG002
value
4.5
title
Liver irAEs (any grade)
categories
measurements
group Id
OG000
value
1.1
group Id
OG001
value
0.8
group Id
OG002
value
2.3
title
Severe (>= Grade 3) Liver irAEs
categories
measurements
group Id
OG000
value
3.9
group Id
OG001
value
7.6
group Id
OG002
value
1.5
title
Endocrine irAEs (any grade)
categories
measurements
group Id
OG000
value
1.1
group Id
OG001
value
3.8
group Id
OG002
value
0
title
Severe (>= Grade 3) Endocrine irAEs
categories
measurements
group Id
OG000
value
40.0
group Id
OG001
value
43.5
group Id
OG002
value
16.7
title
Skin irAEs (any grade)

denoms

counts
group Id
OG000
value
380
group Id
OG001
value
131
group Id
OG002
value
132
units
Participants

description

groups

description
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
id
OG000
title
Ipilimumab Plus gp100
description
Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
id
OG001
title
Ipilimumab Monotherapy
description
Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
id
OG002
title
gp100

param Type

NUMBER

population Description

All subjects who received at least 1 dose or any partial dose of study medication.

reporting Status

POSTED

time Frame

On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).

title

Percentage of Participants With Immune-Related Adverse Events (irAEs)

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice