NCT01847274 · OUTCOME

Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days

What was measured

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.

Analysis population: Intent-to-treat population

Groups in this outcome

gBRCA Niraparib

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.

gBRCA Placebo

Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.

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

Analysis denominator · Participants

Group	Source count
gBRCA Niraparib	138
gBRCA Placebo	65

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
gBRCA Niraparib	19.1	Not reported	14.6	21.9	Not reported
gBRCA Placebo	8.6	Not reported	6.9	12.2	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.412
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.783
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0005
p Value Comment
Two-sided p-value
param Type
Hazard Ratio (HR)
param Value
0.57
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.412
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.783
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0005
p Value Comment
Two-sided p-value
param Type
Hazard Ratio (HR)
param Value
0.57
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
14.6
upper Limit
21.9
value
19.1
group Id
OG001
lower Limit
6.9
upper Limit
12.2
value
8.6

denoms

counts
group Id
OG000
value
138
group Id
OG001
value
65
units
Participants

description

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.

dispersion Type

95% Confidence Interval

groups

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.
id
OG000
title
gBRCA Niraparib
description
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
id
OG001
title
gBRCA Placebo

param Type

MEDIAN

population Description

Intent-to-treat population

reporting Status

POSTED

time Frame

From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days

title

Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice