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NCT02094573 · OUTCOME

Time on Treatment

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
days
Interval / dispersion
Full Range
Time frame
Up to approximately 69 months

What was measured

Time on treatment was defined as the time from the first to the last dose of study drug. For participants who have not discontinued, time on treatment was censored as of the last dose of the study drug.

Analysis population: Safety Population included all participants who received at least one dose of study drug.

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

GroupSource count
Brigatinib 90 mg109
Brigatinib 90 mg - 180 mg110

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Brigatinib 90 mg402.0Not reported11882Not reported
Brigatinib 90 mg - 180 mg522.0Not reported22030Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1882
        value
        402.0
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        2030
        value
        522.0
denoms
  1. counts
    1. group Id
      OG000
      value
      109
    2. group Id
      OG001
      value
      110
    units
    Participants
description
Time on treatment was defined as the time from the first to the last dose of study drug. For participants who have not discontinued, time on treatment was censored as of the last dose of the study drug.
dispersion Type
Full Range
groups
  1. 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
  2. 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
Safety Population included all participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Up to approximately 69 months
title
Time on Treatment
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice