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NCT03675737 · OUTCOME

Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859) · Source last updated 2026-02-27

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 46.3 months

What was measured

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.

Analysis population: The analysis population included all participants who received at least one dose of study treatment.

Groups in this outcome

Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Placebo + Chemotherapy (FP or CAPOX Regimen)

Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).

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 + Chemotherapy (FP or CAPOX Regimen)785
Placebo + Chemotherapy (FP or CAPOX Regimen)787

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)267Not reportedNot reportedNot reportedNot reported
Placebo + Chemotherapy (FP or CAPOX Regimen)206Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        267
      2. group Id
        OG001
        value
        206
denoms
  1. counts
    1. group Id
      OG000
      value
      785
    2. group Id
      OG001
      value
      787
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
    id
    OG000
    title
    Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
  2. description
    Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
    id
    OG001
    title
    Placebo + Chemotherapy (FP or CAPOX Regimen)
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population included all participants who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 46.3 months
title
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice