Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02657889 · OUTCOME

Phase 2: Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
Up to a maximum of 54 months

What was measured

OS is defined as the time from date of first dose of study treatment to the date of death by any cause.

Analysis population: Full Analysis Set. Only those participants with data available at specified time point 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 200mg + 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 200mg + Pembrolizumab55

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200 mg + Pembrolizumab17.1Not reported7.9NA\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab9.4Not reported3.222.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
        group Id
        OG000
        lower Limit
        7.9
        upper Limit
        NA
        value
        17.1
      2. group Id
        OG001
        lower Limit
        3.2
        upper Limit
        22.2
        value
        9.4
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      55
    units
    Participants
description
OS is defined as the time from date of first dose of study treatment to the date of death by any cause.
dispersion Type
Inter-Quartile Range
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 200mg + Pembrolizumab
param Type
MEDIAN
population Description
Full Analysis Set. Only those participants with data available at specified time point were analyzed.
reporting Status
POSTED
time Frame
Up to a maximum of 54 months
title
Phase 2: Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice