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NCT02504372 · OUTCOME

Number of Participants Who Experienced an Adverse Event (AE)

Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091) · Source last updated 2026-03-17

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
Up to approximately 22 months

What was measured

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who experienced an AE were reported.

Analysis population: All randomized participants who received at least one dose of study treatment.

Groups in this outcome

Pembrolizumab

Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.

Placebo

Participants received placebo, IV, every 3 weeks, for one year.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab580
Placebo581

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab556Not reportedNot reportedNot reportedNot reported
Placebo529Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        556
      2. group Id
        OG001
        value
        529
denoms
  1. counts
    1. group Id
      OG000
      value
      580
    2. group Id
      OG001
      value
      581
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who experienced an AE were reported.
groups
  1. description
    Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
    id
    OG000
    title
    Pembrolizumab
  2. description
    Participants received placebo, IV, every 3 weeks, for one year.
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 22 months
title
Number of Participants Who Experienced an Adverse Event (AE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice