Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02094573 · OUTCOME

Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From first dose of study drug up to 30 days following the last dose of study drug (approximately up to 69 months)

What was measured

An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving 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 participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brigatinib 90 mg109Not reportedNot reportedNot reportedNot reported
Brigatinib 90 mg - 180 mg110Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        110
denoms
  1. counts
    1. group Id
      OG000
      value
      109
    2. group Id
      OG001
      value
      110
    units
    Participants
description
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
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
NUMBER
population Description
Safety Population included all participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From first dose of study drug up to 30 days following the last dose of study drug (approximately up to 69 months)
title
Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice