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NCT00949650 · OUTCOME

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Throughout the trial until progression (every 3 weeks), up to 28 months.

What was measured

ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work. 2. Ambulatory (\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities. 3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Dead.

Analysis population: RS. Only patients with baseline and at least one post-baseline assessment were included.

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 mg228
Pemetrexed/Cisplatin Chemotherapy111

Reported measurements

ECOG PS 0 (last value)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 mg92Not reportedNot reportedNot reportedNot reported
Pemetrexed/Cisplatin Chemotherapy41Not reportedNot reportedNot reportedNot reported
ECOG PS 1 (last value)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 mg138Not reportedNot reportedNot reportedNot reported
Pemetrexed/Cisplatin Chemotherapy73Not reportedNot reportedNot reportedNot reported
ECOG PS 2 (last value)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 mg0Not reportedNot reportedNot reportedNot reported
Pemetrexed/Cisplatin Chemotherapy1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        41
    title
    ECOG PS 0 (last value)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        138
      2. group Id
        OG001
        value
        73
    title
    ECOG PS 1 (last value)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    ECOG PS 2 (last value)
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    2. group Id
      OG001
      value
      111
    units
    Participants
description
ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work. 2. Ambulatory (\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities. 3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Dead.
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
NUMBER
population Description
RS. Only patients with baseline and at least one post-baseline assessment were included.
reporting Status
POSTED
time Frame
Throughout the trial until progression (every 3 weeks), up to 28 months.
title
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice