Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01847274 · OUTCOME

Number of Participants With Non-serious AEs and SAEs in QTc Sub-study

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 5 years 10 months and 22 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.

Analysis population: Safety Population

Groups in this outcome

QTc Sub-study: Niraparib

Participants received Niraparib 300 mg once daily orally.

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

Analysis denominator · Participants

GroupSource count
QTc Sub-study: Niraparib26

Reported measurements

Non-serious AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
QTc Sub-study: Niraparib24Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
QTc Sub-study: Niraparib12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Non-serious AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    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.
groups
  1. description
    Participants received Niraparib 300 mg once daily orally.
    id
    OG000
    title
    QTc Sub-study: Niraparib
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population
reporting Status
POSTED
time Frame
Up to 5 years 10 months and 22 days
title
Number of Participants With Non-serious AEs and SAEs in QTc Sub-study
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice