NCT00949650 · OUTCOME

Percentage of Patients With Objective Response (OR)

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: Percentage of patients with OR.
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

OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.

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 Percentage of patients with OR. · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Afatinib 40 mg	56.5	Not reported	49.8	63.0	Not reported
Pemetrexed/Cisplatin Chemotherapy	22.6	Not reported	15.3	31.3	Not reported

Source statistical analyses

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

ci Lower Limit
2.855
ci Pct Value
95
ci Upper Limit
8.075
estimate Comment
Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
4.802
statistical Comment
Logistic regression stratified for EGFR mutation group and race.
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
2.855
ci Pct Value
95
ci Upper Limit
8.075
estimate Comment
Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
4.802
statistical Comment
Logistic regression stratified for EGFR mutation group and race.
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
lower Limit
49.8
upper Limit
63.0
value
56.5
group Id
OG001
lower Limit
15.3
upper Limit
31.3
value
22.6

denoms

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

description

OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.

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

NUMBER

population Description

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

Percentage of Patients With Objective Response (OR)

type

SECONDARY

unit Of Measure

Percentage of patients with OR.

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

Preserved source evidence · Not medical advice