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NCT02362594 · OUTCOME

Number of Participants Who Experienced At Least 1 Adverse Event (AE)

Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) · Source last updated 2026-03-05

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
Up to 22 months

What was measured

An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who experienced at least 1 AE was reported for all participants in each treatment arm.

Analysis population: All randomized participants in Part 1 who received at least 1 dose of study treatment.

Groups in this outcome

Pembrolizumab

In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.

Placebo

In Part 1, participants received placebo IV as post-surgery therapy Q3W.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab509
Placebo502

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab475Not reportedNot reportedNot reportedNot reported
Placebo453Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        475
      2. group Id
        OG001
        value
        453
denoms
  1. counts
    1. group Id
      OG000
      value
      509
    2. group Id
      OG001
      value
      502
    units
    Participants
description
An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who experienced at least 1 AE was reported for all participants in each treatment arm.
groups
  1. description
    In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
    id
    OG000
    title
    Pembrolizumab
  2. description
    In Part 1, participants received placebo IV as post-surgery therapy Q3W.
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants in Part 1 who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Up to 22 months
title
Number of Participants Who Experienced At Least 1 Adverse Event (AE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice