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NCT02657889 · OUTCOME

Phase 2: Number of Participants With TEAEs

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer · Source last updated 2022-12-01

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 a maximum of 54 months

What was measured

An adverse event was any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TEAEs were any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.

Analysis population: Safety Analysis Set. Only those participants with data available at specified time points were analyzed.

Groups in this outcome

Phase 2 OC: Niraparib 200 mg + Pembrolizumab

Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab

Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 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
Phase 2 OC: Niraparib 200 mg + Pembrolizumab53
Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab55

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200 mg + Pembrolizumab53Not reportedNot reportedNot reportedNot reported
Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab54Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        54
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      55
    units
    Participants
description
An adverse event was any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TEAEs were any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.
groups
  1. description
    Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Phase 2 OC: Niraparib 200 mg + Pembrolizumab
  2. description
    Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    OG001
    title
    Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Analysis Set. Only those participants with data available at specified time points were analyzed.
reporting Status
POSTED
time Frame
Up to a maximum of 54 months
title
Phase 2: Number of Participants With TEAEs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice