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NCT01847274 · OUTCOME

Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer · Source last updated 2023-06-02

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 8 months, 26 days

What was measured

An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

Analysis population: Safety Population.

Groups in this outcome

gBRCA Niraparib (PSU)

Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 1-Apr-2021 to 26-Dec-2021.

gBRCA Placebo (PSU)

Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

Non-gBRCA Niraparib (PSU)

Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

Non-gBRCA Placebo (PSU)

Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

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

Analysis denominator · Participants

GroupSource count
gBRCA Niraparib (PSU)22
gBRCA Placebo (PSU)8
Non-gBRCA Niraparib (PSU)31
Non-gBRCA Placebo (PSU)13

Reported measurements

Non-serious AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
gBRCA Niraparib (PSU)0Not reportedNot reportedNot reportedNot reported
gBRCA Placebo (PSU)0Not reportedNot reportedNot reportedNot reported
Non-gBRCA Niraparib (PSU)0Not reportedNot reportedNot reportedNot reported
Non-gBRCA Placebo (PSU)0Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
gBRCA Niraparib (PSU)0Not reportedNot reportedNot reportedNot reported
gBRCA Placebo (PSU)0Not reportedNot reportedNot reportedNot reported
Non-gBRCA Niraparib (PSU)0Not reportedNot reportedNot reportedNot reported
Non-gBRCA Placebo (PSU)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Non-serious AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      31
    4. group Id
      OG003
      value
      13
    units
    Participants
description
An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
groups
  1. description
    Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 1-Apr-2021 to 26-Dec-2021.
    id
    OG000
    title
    gBRCA Niraparib (PSU)
  2. description
    Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
    id
    OG001
    title
    gBRCA Placebo (PSU)
  3. description
    Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
    id
    OG002
    title
    Non-gBRCA Niraparib (PSU)
  4. description
    Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
    id
    OG003
    title
    Non-gBRCA Placebo (PSU)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population.
reporting Status
POSTED
time Frame
Up to 8 months, 26 days
title
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice