NCT00949650 · OUTCOME

Overall Survival (OS) 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: From randomisation to cut-off date (17MAR2017).

What was measured

OS was defined as time from randomisation to death.

Analysis population: 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

Group	Source count
Afatinib 40 mg	230
Pemetrexed/Cisplatin Chemotherapy	115

Reported measurements

Source class 1

Values in Months. · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Afatinib 40 mg	28.16	Not reported	24.64	33.58	Not reported
Pemetrexed/Cisplatin Chemotherapy	28.22	Not reported	20.73	33.22	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7916
p Value Comment
Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
statistical Method
Log Rank
ci Lower Limit
0.660
ci Pct Value
95
ci Upper Limit
1.174
estimate Comment
Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3850
param Type
Hazard Ratio (HR)
param Value
0.880
statistical Comment
Cox PH regression stratified by EGFR mutation group and race.
statistical Method
Regression, Cox

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7916
p Value Comment
Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
statistical Method
Log Rank
ci Lower Limit
0.660
ci Pct Value
95
ci Upper Limit
1.174
estimate Comment
Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3850
param Type
Hazard Ratio (HR)
param Value
0.880
statistical Comment
Cox PH regression stratified by EGFR mutation group and race.
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
24.64
upper Limit
33.58
value
28.16
group Id
OG001
lower Limit
20.73
upper Limit
33.22
value
28.22

denoms

counts
group Id
OG000
value
230
group Id
OG001
value
115
units
Participants

description

OS was defined as time from randomisation to death.

dispersion Type

95% Confidence Interval

groups

description
Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
id
OG000
title
Afatinib 40 mg
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

RS.

reporting Status

POSTED

time Frame

From randomisation to cut-off date (17MAR2017).

title

Overall Survival (OS) Time

type

SECONDARY

unit Of Measure

Months.

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

Preserved source evidence · Not medical advice