NCT02184195 · OUTCOME

Time From Randomisation to First Subsequent Therapy or Death (TFST)

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy · Source last updated 2023-09-13

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: Up to 4 years

What was measured

To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.

Analysis population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

Groups in this outcome

Olaparib 300 mg Twice Daily (bd)

Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

Placebo

Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

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
Olaparib 300 mg Twice Daily (bd)	92
Placebo	62

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Olaparib 300 mg Twice Daily (bd)	9.0	Not reported	6.21	12.85	Not reported
Placebo	5.4	Not reported	3.94	6.21	Not reported

Source statistical analyses

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

ci Lower Limit
0.297
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.658
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.442
statistical Method
Log-rank test

Complete source fields

analyses

ci Lower Limit
0.297
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.658
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.442
statistical Method
Log-rank test

classes

categories
measurements
group Id
OG000
lower Limit
6.21
upper Limit
12.85
value
9.0
group Id
OG001
lower Limit
3.94
upper Limit
6.21
value
5.4

denoms

counts
group Id
OG000
value
92
group Id
OG001
value
62
units
Participants

description

To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.

dispersion Type

95% Confidence Interval

groups

description
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
id
OG000
title
Olaparib 300 mg Twice Daily (bd)
description
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
id
OG001
title
Placebo

param Type

MEDIAN

population Description

Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

reporting Status

POSTED

time Frame

Up to 4 years

title

Time From Randomisation to First Subsequent Therapy or Death (TFST)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice