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NCT02388906 · OUTCOME

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma · Source last updated 2025-04-24

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
reported between the first dose and 30 days after last dose of study therapy

What was measured

The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

Analysis population: all treated participants

Groups in this outcome

Nivolumab 3 mg/kg

Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24

Ipilimumab 10 mg/kg

Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg452
Ipilimumab 10 mg/kg453

Reported measurements

Grade 3-4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg48Not reportedNot reportedNot reportedNot reported
Ipilimumab 10 mg/kg145Not reportedNot reportedNot reportedNot reported
Any grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg80Not reportedNot reportedNot reportedNot reported
Ipilimumab 10 mg/kg184Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        145
    title
    Grade 3-4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        184
    title
    Any grade
denoms
  1. counts
    1. group Id
      OG000
      value
      452
    2. group Id
      OG001
      value
      453
    units
    Participants
description
The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events
groups
  1. description
    Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
    id
    OG000
    title
    Nivolumab 3 mg/kg
  2. description
    Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
    id
    OG001
    title
    Ipilimumab 10 mg/kg
param Type
NUMBER
population Description
all treated participants
reporting Status
POSTED
time Frame
reported between the first dose and 30 days after last dose of study therapy
title
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice