NCT02094573 · OUTCOME

Overall Survival (OS)

A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib · Source last updated 2021-03-15

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 approximately 69 months

What was measured

OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. Intracranial OS was calculated by Kaplan-Meier estimation.

Analysis population: ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.

Groups in this outcome

Brigatinib 90 mg

Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).

Brigatinib 90 mg - 180 mg

Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).

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
Brigatinib 90 mg	112
Brigatinib 90 mg - 180 mg	110

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	25.9	Not reported	18.2	45.8	Not reported
Brigatinib 90 mg - 180 mg	40.6	Not reported	32.5	NA	Upper limit of 95% confidence interval was not estimable due to low number of participants with event.

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
18.2
upper Limit
45.8
value
25.9
comment
Upper limit of 95% confidence interval was not estimable due to low number of participants with event.
group Id
OG001
lower Limit
32.5
upper Limit
NA
value
40.6

denoms

counts
group Id
OG000
value
112
group Id
OG001
value
110
units
Participants

description

OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. Intracranial OS was calculated by Kaplan-Meier estimation.

dispersion Type

95% Confidence Interval

groups

description
Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
id
OG000
title
Brigatinib 90 mg
description
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
id
OG001
title
Brigatinib 90 mg - 180 mg

param Type

MEDIAN

population Description

ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.

reporting Status

POSTED

time Frame

Up to approximately 69 months

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice