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NCT00094653 · OUTCOME

Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death

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 AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.

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

GroupSource count
Ipilimumab Plus gp100380
Ipilimumab Monotherapy131
gp100132

Reported measurements

Any On-Study AE
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10098.4Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy96.9Not reportedNot reportedNot reportedNot reported
gp10097.0Not reportedNot reportedNot reportedNot reported
Severe (>=Grade 3) On-Study AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10050.8Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy55.0Not reportedNot reportedNot reportedNot reported
gp10052.3Not reportedNot reportedNot reportedNot reported
Serious On-Study AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10040.8Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy42.0Not reportedNot reportedNot reportedNot reported
gp10039.4Not reportedNot reportedNot reportedNot reported
Related On-Study AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10088.9Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy80.2Not reportedNot reportedNot reportedNot reported
gp10078.8Not reportedNot reportedNot reportedNot reported
On-Study AEs Leading to Discontinuation
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1009.2Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy13.0Not reportedNot reportedNot reportedNot reported
gp1003.8Not reportedNot reportedNot reportedNot reported
AEs with Outcome of Death
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1006.1Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy9.9Not reportedNot reportedNot reportedNot reported
gp1006.1Not reportedNot reportedNot reportedNot reported
Related AE with Outcome of Death
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1002.1Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy3.1Not reportedNot reportedNot reportedNot reported
gp1001.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        98.4
      2. group Id
        OG001
        value
        96.9
      3. group Id
        OG002
        value
        97.0
    title
    Any On-Study AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        50.8
      2. group Id
        OG001
        value
        55.0
      3. group Id
        OG002
        value
        52.3
    title
    Severe (>=Grade 3) On-Study AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        40.8
      2. group Id
        OG001
        value
        42.0
      3. group Id
        OG002
        value
        39.4
    title
    Serious On-Study AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        88.9
      2. group Id
        OG001
        value
        80.2
      3. group Id
        OG002
        value
        78.8
    title
    Related On-Study AEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9.2
      2. group Id
        OG001
        value
        13.0
      3. group Id
        OG002
        value
        3.8
    title
    On-Study AEs Leading to Discontinuation
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6.1
      2. group Id
        OG001
        value
        9.9
      3. group Id
        OG002
        value
        6.1
    title
    AEs with Outcome of Death
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2.1
      2. group Id
        OG001
        value
        3.1
      3. group Id
        OG002
        value
        1.5
    title
    Related AE with Outcome of Death
denoms
  1. counts
    1. group Id
      OG000
      value
      380
    2. group Id
      OG001
      value
      131
    3. group Id
      OG002
      value
      132
    units
    Participants
description
An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.
groups
  1. 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
  2. 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
  3. 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 On-Study Adverse Events (AEs) and AEs With an Outcome of Death
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice