NCT00094653 · OUTCOME

Percentage of Participants With Worst On-Study Hematological 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 laboratory results are results reported after the first dose date and within 70 days of 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

ANC=Absolute Neutrophil Count. 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

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

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	48.9	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	44.6	Not reported	Not reported	Not reported	Not reported
gp100	46.8	Not reported	Not reported	Not reported	Not reported

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

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	37.2	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	40.5	Not reported	Not reported	Not reported	Not reported
gp100	34.1	Not reported	Not reported	Not reported	Not reported

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

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	12.2	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	14.0	Not reported	Not reported	Not reported	Not reported
gp100	15.1	Not reported	Not reported	Not reported	Not reported

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

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.7	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	0.8	Not reported	Not reported	Not reported	Not reported
gp100	4.0	Not reported	Not reported	Not reported	Not reported

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

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

Hemoglobin, 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	51.1	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	55.4	Not reported	Not reported	Not reported	Not reported
gp100	53.2	Not reported	Not reported	Not reported	Not reported

Hemoglobin, 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	0.8	Not reported	Not reported	Not reported	Not reported
gp100	4.0	Not reported	Not reported	Not reported	Not reported

White Blood Cells, Grade 0 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	97.2	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	95.9	Not reported	Not reported	Not reported	Not reported
gp100	92.9	Not reported	Not reported	Not reported	Not reported

White Blood Cells, Grade 1 (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	5.6	Not reported	Not reported	Not reported	Not reported

White Blood Cells, Grade 2 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	1.1	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	2.5	Not reported	Not reported	Not reported	Not reported
gp100	1.6	Not reported	Not reported	Not reported	Not reported

White Blood Cells, Grade 3 (n=352, 121, 126)

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

White Blood Cells, Grade 4 (n=352, 121, 126)

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

White Blood Cells, 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	2.8	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	4.1	Not reported	Not reported	Not reported	Not reported
gp100	7.1	Not reported	Not reported	Not reported	Not reported

White Blood Cells, 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	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

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

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	96.0	Not reported	Not reported	Not reported	Not reported

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

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	2.8	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

ANC, Grade 2 (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	2.5	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

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

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

ANC, 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

ANC, 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	4.5	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	6.6	Not reported	Not reported	Not reported	Not reported
gp100	4.0	Not reported	Not reported	Not reported	Not reported

ANC, 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	0.9	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	0.8	Not reported	Not reported	Not reported	Not reported
gp100	0.8	Not reported	Not reported	Not reported	Not reported

Platelet Count, Grade 0 (n=349, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	94.6	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	90.1	Not reported	Not reported	Not reported	Not reported
gp100	91.3	Not reported	Not reported	Not reported	Not reported

Platelet Count, Grade 1 (n=349, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	4.9	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	9.1	Not reported	Not reported	Not reported	Not reported
gp100	8.7	Not reported	Not reported	Not reported	Not reported

Platelet Count, Grade 2 (n=349, 121, 126)

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

Platelet Count, Grade 3 (n=349, 121, 126)

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

Platelet Count, Grade 4 (n=349, 121, 126)

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

Platelet Count, Grade 1-4 (n=349, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	5.4	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	9.9	Not reported	Not reported	Not reported	Not reported
gp100	8.7	Not reported	Not reported	Not reported	Not reported

Platelet Count, Grade 3-4 (n=349, 121, 126)

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

Lymphocytes (absolute), Grade 0 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	33.8	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	34.7	Not reported	Not reported	Not reported	Not reported
gp100	22.2	Not reported	Not reported	Not reported	Not reported

Lymphocytes (absolute), Grade 1 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	46.3	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	47.9	Not reported	Not reported	Not reported	Not reported
gp100	42.9	Not reported	Not reported	Not reported	Not reported

Lymphocytes (absolute), Grade 2 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	15.1	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	14.9	Not reported	Not reported	Not reported	Not reported
gp100	25.4	Not reported	Not reported	Not reported	Not reported

Lymphocytes (absolute), Grade 3 (n=352, 121, 126)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab Plus gp100	4.3	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	2.5	Not reported	Not reported	Not reported	Not reported
gp100	9.5	Not reported	Not reported	Not reported	Not reported

Lymphocytes (absolute), Grade 4 (n=352, 121, 126)

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

Lymphocytes (absolute), 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	66.2	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	65.3	Not reported	Not reported	Not reported	Not reported
gp100	77.8	Not reported	Not reported	Not reported	Not reported

Lymphocytes (absolute), 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	4.8	Not reported	Not reported	Not reported	Not reported
Ipilimumab Monotherapy	2.5	Not reported	Not reported	Not reported	Not reported
gp100	9.5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
48.9
group Id
OG001
value
44.6
group Id
OG002
value
46.8
title
Hemoglobin, Grade 0 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
37.2
group Id
OG001
value
40.5
group Id
OG002
value
34.1
title
Hemoglobin, Grade 1 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
12.2
group Id
OG001
value
14.0
group Id
OG002
value
15.1
title
Hemoglobin, Grade 2 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
1.7
group Id
OG001
value
0.8
group Id
OG002
value
4.0
title
Hemoglobin, Grade 3 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Hemoglobin, Grade 4 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
51.1
group Id
OG001
value
55.4
group Id
OG002
value
53.2
title
Hemoglobin, Grade 1-4 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
1.7
group Id
OG001
value
0.8
group Id
OG002
value
4.0
title
Hemoglobin, Grade 3-4 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
97.2
group Id
OG001
value
95.9
group Id
OG002
value
92.9
title
White Blood Cells, Grade 0 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
1.4
group Id
OG001
value
1.7
group Id
OG002
value
5.6
title
White Blood Cells, Grade 1 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
1.1
group Id
OG001
value
2.5
group Id
OG002
value
1.6
title
White Blood Cells, Grade 2 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
0.3
group Id
OG001
value
0
group Id
OG002
value
0
title
White Blood Cells, Grade 3 (n=352, 121, 126)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
White Blood Cells, 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 laboratory results are results reported after the first dose date and within 70 days of 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 Hematological Abnormalities

type

SECONDARY

unit Of Measure

percentage of participants

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