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NCT00636168 · OUTCOME

Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population

Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma · Source last updated 2019-12-17

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1 up to 70 days after last dose; up to 5 years

What was measured

AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator's assessment of immune-mediated etiology \[excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)\]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.

Analysis population: Safety population: All randomized participants who received at least 1 dose of study therapy

Groups in this outcome

Ipilimumab 10mg/kg

Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).

Placebo

Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).

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 10mg/kg471
Placebo474

Reported measurements

On-study AE leading to Discontinuation (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg247Not reportedNot reportedNot reportedNot reported
Placebo43Not reportedNot reportedNot reportedNot reported
On-study SAE (At least 5%, Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg257Not reportedNot reportedNot reportedNot reported
Placebo128Not reportedNot reportedNot reportedNot reported
On-study D-R SAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg217Not reportedNot reportedNot reportedNot reported
Placebo10Not reportedNot reportedNot reportedNot reported
On-study irAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg426Not reportedNot reportedNot reportedNot reported
Placebo188Not reportedNot reportedNot reportedNot reported
On-study gastrointestinal irAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg217Not reportedNot reportedNot reportedNot reported
Placebo85Not reportedNot reportedNot reportedNot reported
On-study endocrine irAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg178Not reportedNot reportedNot reportedNot reported
Placebo38Not reportedNot reportedNot reportedNot reported
On-study liver irAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg115Not reportedNot reportedNot reportedNot reported
Placebo20Not reportedNot reportedNot reportedNot reported
On-study skin irAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg298Not reportedNot reportedNot reportedNot reported
Placebo99Not reportedNot reportedNot reportedNot reported
On-study neurological irAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg21Not reportedNot reportedNot reportedNot reported
Placebo9Not reportedNot reportedNot reportedNot reported
On-study other irAE (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg111Not reportedNot reportedNot reportedNot reported
Placebo23Not reportedNot reportedNot reportedNot reported
On-study imAR (Grade 3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg194Not reportedNot reportedNot reportedNot reported
Placebo16Not reportedNot reportedNot reportedNot reported
On-study imAR (Grade 5)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
On-study enterocolitis imAR (Grade 5)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
On-study enterocolitis imAR (Grade 3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg76Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
On-study endocrinopathy imAR (Grade 3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg39Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
On-study hepatitis imAR (Grade 3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg51Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
On-study dermatitis imAR (Grade 3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg19Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
On-study neuropathy imAR (Grade 3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg10Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
On-study other imAR (Grade 3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg30Not reportedNot reportedNot reportedNot reported
Placebo9Not reportedNot reportedNot reportedNot reported
Any Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg162Not reportedNot reportedNot reportedNot reported
Placebo214Not reportedNot reportedNot reportedNot reported
Death within 70 days of last dose study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg6Not reportedNot reportedNot reportedNot reported
Placebo6Not reportedNot reportedNot reportedNot reported
Death within 30 days of last dose study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Drug-related Deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg4Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        247
      2. group Id
        OG001
        value
        43
    title
    On-study AE leading to Discontinuation (Any Grade)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        257
      2. group Id
        OG001
        value
        128
    title
    On-study SAE (At least 5%, Any Grade)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        217
      2. group Id
        OG001
        value
        10
    title
    On-study D-R SAE (Any Grade)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        426
      2. group Id
        OG001
        value
        188
    title
    On-study irAE (Any Grade)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        217
      2. group Id
        OG001
        value
        85
    title
    On-study gastrointestinal irAE (Any Grade)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        178
      2. group Id
        OG001
        value
        38
    title
    On-study endocrine irAE (Any Grade)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        20
    title
    On-study liver irAE (Any Grade)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        298
      2. group Id
        OG001
        value
        99
    title
    On-study skin irAE (Any Grade)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        9
    title
    On-study neurological irAE (Any Grade)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        111
      2. group Id
        OG001
        value
        23
    title
    On-study other irAE (Any Grade)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        194
      2. group Id
        OG001
        value
        16
    title
    On-study imAR (Grade 3-4)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    On-study imAR (Grade 5)
denoms
  1. counts
    1. group Id
      OG000
      value
      471
    2. group Id
      OG001
      value
      474
    units
    Participants
description
AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator's assessment of immune-mediated etiology \[excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)\]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.
groups
  1. description
    Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
    id
    OG000
    title
    Ipilimumab 10mg/kg
  2. description
    Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population: All randomized participants who received at least 1 dose of study therapy
reporting Status
POSTED
time Frame
Day 1 up to 70 days after last dose; up to 5 years
title
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice