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NCT02819518 · OUTCOME

Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355) · Source last updated 2024-11-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 39 months

What was measured

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Analysis population: All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.

Groups in this outcome

Part 1: Pembrolizumab + Nab-Paclitaxel

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.

Part 1: Pembrolizumab + Paclitaxel

Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.

Part 1: Pembrolizumab + Gemcitabine/Carboplatin

Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Part 1: Pembrolizumab + Nab-Paclitaxel13
Part 1: Pembrolizumab + Paclitaxel10
Part 1: Pembrolizumab + Gemcitabine/Carboplatin11

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Pembrolizumab + Nab-Paclitaxel100.0Not reportedNot reportedNot reportedNot reported
Part 1: Pembrolizumab + Paclitaxel100.0Not reportedNot reportedNot reportedNot reported
Part 1: Pembrolizumab + Gemcitabine/Carboplatin100.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
      3. group Id
        OG002
        value
        100.0
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      11
    units
    Participants
description
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
    id
    OG000
    title
    Part 1: Pembrolizumab + Nab-Paclitaxel
  2. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
    id
    OG001
    title
    Part 1: Pembrolizumab + Paclitaxel
  3. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
    id
    OG002
    title
    Part 1: Pembrolizumab + Gemcitabine/Carboplatin
param Type
NUMBER
population Description
All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.
reporting Status
POSTED
time Frame
Up to approximately 39 months
title
Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice