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NCT01847274 · OUTCOME

Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds

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
At Baseline (Cycle 1 Day 1, each cycle was of 28 days)

What was measured

12-lead electrocardiogram was obtained at indicated time points using an automated electrocardiogram machine that measured QTcF interval. The number of participants with maximum post-Baseline ECG value exceeding the following limits have been reported: QTcF interval \>450 and \<= 480 milliseconds (msec) and \>500 msec.

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

>450 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
QTc Sub-study: Niraparib2Not reportedNot reportedNot reportedNot reported
>480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
QTc Sub-study: Niraparib0Not reportedNot reportedNot reportedNot reported
>500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
QTc Sub-study: Niraparib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    >450 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    >480 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    >500 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
12-lead electrocardiogram was obtained at indicated time points using an automated electrocardiogram machine that measured QTcF interval. The number of participants with maximum post-Baseline ECG value exceeding the following limits have been reported: QTcF interval \>450 and \<= 480 milliseconds (msec) and \>500 msec.
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
At Baseline (Cycle 1 Day 1, each cycle was of 28 days)
title
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice