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NCT00949650 · OUTCOME

Change From Baseline in Body Weight

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
MEAN
Unit
Kg.
Interval / dispersion
Standard Deviation
Time frame
Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.

What was measured

Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.

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 mg224
Pemetrexed/Cisplatin Chemotherapy109

Reported measurements

Change from baseline at lowest value
Values in Kg. · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Afatinib 40 mg-3.953.91Not reportedNot reportedNot reported
Pemetrexed/Cisplatin Chemotherapy-2.682.90Not reportedNot reportedNot reported
Change from baseline at last value
Values in Kg. · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Afatinib 40 mg-1.195.36Not reportedNot reportedNot reported
Pemetrexed/Cisplatin Chemotherapy-0.294.02Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.91
        value
        -3.95
      2. group Id
        OG001
        spread
        2.90
        value
        -2.68
    title
    Change from baseline at lowest value
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.36
        value
        -1.19
      2. group Id
        OG001
        spread
        4.02
        value
        -0.29
    title
    Change from baseline at last value
denoms
  1. counts
    1. group Id
      OG000
      value
      224
    2. group Id
      OG001
      value
      109
    units
    Participants
description
Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.
dispersion Type
Standard Deviation
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
MEAN
population Description
RS. Only patients with baseline and at least one post-baseline assessment were included.
reporting Status
POSTED
time Frame
Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.
title
Change From Baseline in Body Weight
type
SECONDARY
unit Of Measure
Kg.

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

Preserved source evidence · Not medical advice