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NCT02494583 · OUTCOME

Number of Participants Discontinuing Study Treatment Due to an AE

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062) · Source last updated 2023-04-13

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 30 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 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 who discontinued study treatment due to an AE was reported for each arm according to the treatment received.

Analysis population: All randomized participants who received at least 1 dose of trial treatment were analyzed.

Groups in this outcome

Pembrolizumab Monotherapy (Pembro Mono)

Participants received pembrolizumab 200 mg IV Q3W.

Pembrolizumab + SOC Chemotherapy (Pembro Combo)

Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.

Placebo + SOC Chemotherapy (SOC)

Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.

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 Monotherapy (Pembro Mono)254
Pembrolizumab + SOC Chemotherapy (Pembro Combo)250
Placebo + SOC Chemotherapy (SOC)244

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab Monotherapy (Pembro Mono)29Not reportedNot reportedNot reportedNot reported
Pembrolizumab + SOC Chemotherapy (Pembro Combo)85Not reportedNot reportedNot reportedNot reported
Placebo + SOC Chemotherapy (SOC)58Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        85
      3. group Id
        OG002
        value
        58
denoms
  1. counts
    1. group Id
      OG000
      value
      254
    2. group Id
      OG001
      value
      250
    3. group Id
      OG002
      value
      244
    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 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 who discontinued study treatment due to an AE was reported for each arm according to the treatment received.
groups
  1. description
    Participants received pembrolizumab 200 mg IV Q3W.
    id
    OG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    OG001
    title
    Pembrolizumab + SOC Chemotherapy (Pembro Combo)
  3. description
    Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    OG002
    title
    Placebo + SOC Chemotherapy (SOC)
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants who received at least 1 dose of trial treatment were analyzed.
reporting Status
POSTED
time Frame
Up to approximately 30 months
title
Number of Participants Discontinuing 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