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NCT02559687 · OUTCOME

Number of Participants That Discontinued Study Treatment Due to an AE

Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180) · Source last updated 2022-09-14

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 24 months

What was measured

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported per protocol for the first course of treatment.

Analysis population: All allocated participants who received at least 1 dose of study treatment.

Groups in this outcome

Pembrolizumab 200 mg

Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab 200 mg121

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab 200 mg14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported per protocol for the first course of treatment.
groups
  1. description
    Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
    id
    OG000
    title
    Pembrolizumab 200 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
All allocated participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 24 months
title
Number of Participants That Discontinued Study Treatment Due to an AE
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice