NCT00094653 · OUTCOME

Percentage of Participants With Worst On-Study Liver Abnormalities

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

ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.

Analysis population: All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.

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

ALT, Grade 0 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	83.2	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	76.0	Not reported	Not reported	Not reported	Not reported
gp100	84.9	Not reported	Not reported	Not reported	Not reported

ALT, Grade 1 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	13.6	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	19.0	Not reported	Not reported	Not reported	Not reported
gp100	12.7	Not reported	Not reported	Not reported	Not reported

ALT, Grade 2 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	2.0	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	3.3	Not reported	Not reported	Not reported	Not reported
gp100	1.6	Not reported	Not reported	Not reported	Not reported

ALT, Grade 3 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	0.9	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	1.7	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

ALT, Grade 4 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	0.3	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

ALT, Grade 1-4 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	16.8	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	24.0	Not reported	Not reported	Not reported	Not reported
gp100	15.1	Not reported	Not reported	Not reported	Not reported

ALT, Grade 3-4 (n=352, 121, 126)

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	1.7	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

AST, Grade 0 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	80.4	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	71.9	Not reported	Not reported	Not reported	Not reported
gp100	81.7	Not reported	Not reported	Not reported	Not reported

AST, Grade 1 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	16.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	23.1	Not reported	Not reported	Not reported	Not reported
gp100	15.1	Not reported	Not reported	Not reported	Not reported

AST, Grade 2 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.4	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	3.3	Not reported	Not reported	Not reported	Not reported
gp100	2.4	Not reported	Not reported	Not reported	Not reported

AST, Grade 3 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.4	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	1.7	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

AST, Grade 4 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	0.3	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

AST, Grade 1-4 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	19.6	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	28.1	Not reported	Not reported	Not reported	Not reported
gp100	18.3	Not reported	Not reported	Not reported	Not reported

AST, Grade 3-4 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.7	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	1.7	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Total Bilirubin, Grade 0 (n=353, 121, 127)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	95.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	93.4	Not reported	Not reported	Not reported	Not reported
gp100	98.4	Not reported	Not reported	Not reported	Not reported

Total Bilirubin, Grade 1 (n=353, 121, 127)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	2.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	4.1	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Total Bilirubin, Grade 2 (n=353, 121, 127)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.4	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	1.7	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Total Bilirubin, Grade 3 (n=353, 121, 127)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	0.6	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	0.8	Not reported	Not reported	Not reported	Not reported
gp100	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin, Grade 4 (n=353, 121, 127)

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

Total Bilirubin, Grade 1-4 (n=353, 121, 127)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	4.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	6.6	Not reported	Not reported	Not reported	Not reported
gp100	1.6	Not reported	Not reported	Not reported	Not reported

Total Bilirubin, Grade 3-4 (n=353, 121, 127)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	0.6	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	0.8	Not reported	Not reported	Not reported	Not reported
gp100	0	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase, Grade 0 (n=353, 121, 128)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	73.7	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	71.9	Not reported	Not reported	Not reported	Not reported
gp100	71.1	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase, Grade 1 (n=353, 121, 128)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	19.8	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	20.7	Not reported	Not reported	Not reported	Not reported
gp100	24.2	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase, Grade 2 (n=353, 121, 128)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	4.8	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	4.1	Not reported	Not reported	Not reported	Not reported
gp100	3.9	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase, Grade 3 (n=353, 121, 128)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.7	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	3.3	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase, Grade 4 (n=353, 121, 128)

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

Alkaline Phosphatase, Grade 1-4 (n=353, 121, 128)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	26.3	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	28.1	Not reported	Not reported	Not reported	Not reported
gp100	28.9	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase, Grade 3-4 (n=353, 121, 128)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.7	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	3.3	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
83.2
group Id
OG001
value
76.0
group Id
OG002
value
84.9
title
ALT, Grade 0 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
13.6
group Id
OG001
value
19.0
group Id
OG002
value
12.7
title
ALT, Grade 1 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
3.3
group Id
OG002
value
1.6
title
ALT, Grade 2 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
0.9
group Id
OG001
value
1.7
group Id
OG002
value
0.8
title
ALT, Grade 3 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
0.3
group Id
OG001
value
0
group Id
OG002
value
0
title
ALT, Grade 4 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
16.8
group Id
OG001
value
24.0
group Id
OG002
value
15.1
title
ALT, Grade 1-4 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
1.1
group Id
OG001
value
1.7
group Id
OG002
value
0.8
title
ALT, Grade 3-4 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
80.4
group Id
OG001
value
71.9
group Id
OG002
value
81.7
title
AST, Grade 0 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
16.5
group Id
OG001
value
23.1
group Id
OG002
value
15.1
title
AST, Grade 1 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
1.4
group Id
OG001
value
3.3
group Id
OG002
value
2.4
title
AST, Grade 2 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
1.4
group Id
OG001
value
1.7
group Id
OG002
value
0.8
title
AST, Grade 3 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
0.3
group Id
OG001
value
0
group Id
OG002
value
0
title
AST, Grade 4 (n=352, 121, 126)

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. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.

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 Worst On-Study Liver Abnormalities

type

SECONDARY

unit Of Measure

percentage of participants

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