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NCT00949650 · OUTCOME

Progression-Free Survival (PFS) Time

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation · Source last updated 2018-04-06

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
Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression

What was measured

PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.

Analysis population: Randomised set (RS)

Groups in this outcome

Afatinib 40 mg

Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.

Pemetrexed/Cisplatin Chemotherapy

Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.

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

Analysis denominator · Participants

GroupSource count
Afatinib 40 mg230
Pemetrexed/Cisplatin Chemotherapy115

Reported measurements

Source class 1
Values in Months. · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Afatinib 40 mg11.17Not reported9.6313.70Not reported
Pemetrexed/Cisplatin Chemotherapy6.90Not reported5.398.25Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    p Value Comment
    Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.426
    ci Pct Value
    95
    ci Upper Limit
    0.778
    estimate Comment
    Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.576
    statistical Comment
    Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    p Value Comment
    Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.426
    ci Pct Value
    95
    ci Upper Limit
    0.778
    estimate Comment
    Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.576
    statistical Comment
    Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.63
        upper Limit
        13.70
        value
        11.17
      2. group Id
        OG001
        lower Limit
        5.39
        upper Limit
        8.25
        value
        6.90
denoms
  1. counts
    1. group Id
      OG000
      value
      230
    2. group Id
      OG001
      value
      115
    units
    Participants
description
PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    OG000
    title
    Afatinib 40 mg
  2. description
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    id
    OG001
    title
    Pemetrexed/Cisplatin Chemotherapy
param Type
MEDIAN
population Description
Randomised set (RS)
reporting Status
POSTED
time Frame
Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
title
Progression-Free Survival (PFS) Time
type
PRIMARY
unit Of Measure
Months.

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

Preserved source evidence · Not medical advice