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NCT02555657 · OUTCOME

Number of Participants Who Experienced One or More Adverse Events

Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119) · Source last updated 2021-12-10

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 60 months

What was measured

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

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

Groups in this outcome

Pembrolizumab

Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).

Chemotherapy

Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and 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
Pembrolizumab309
Chemotherapy292

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab285Not reportedNot reportedNot reportedNot reported
Chemotherapy281Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        285
      2. group Id
        OG001
        value
        281
denoms
  1. counts
    1. group Id
      OG000
      value
      309
    2. group Id
      OG001
      value
      292
    units
    Participants
description
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
groups
  1. description
    Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).
    id
    OG000
    title
    Pembrolizumab
  2. description
    Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
    id
    OG001
    title
    Chemotherapy
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants who received at least 1 dose of study treatment
reporting Status
POSTED
time Frame
Up to approximately 60 months
title
Number of Participants Who Experienced One or More Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice