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NCT00525148 · OUTCOME

Overall Survival Time

LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations · Source last updated 2016-09-16

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
Start of treatment to time to all death, up to 93 months

What was measured

Overall survival time (OS) was also evaluated and was defined as the duration of time from start of treatment to time of death up to 93 months, regardless of the cause of death. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood's standard error estimate.

Analysis population: Treated set

Groups in this outcome

Afatinib

Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.

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

Analysis denominator · Participants

GroupSource count
Afatinib129

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Afatinib26.8Not reported22.034.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.0
        upper Limit
        34.5
        value
        26.8
denoms
  1. counts
    1. group Id
      OG000
      value
      129
    units
    Participants
description
Overall survival time (OS) was also evaluated and was defined as the duration of time from start of treatment to time of death up to 93 months, regardless of the cause of death. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood's standard error estimate.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
    id
    OG000
    title
    Afatinib
param Type
MEDIAN
population Description
Treated set
reporting Status
POSTED
time Frame
Start of treatment to time to all death, up to 93 months
title
Overall Survival Time
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice