NCT01907100 · OUTCOME

Objective Response According to Modified RECIST- Investigator Assessment

Nintedanib (BIBF 1120) in Mesothelioma · Source last updated 2019-03-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months

What was measured

Objective response (best overall tumour response of confirmed complete response \[CR\] or confirmed partial response \[PR\]). Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement. Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.

Analysis population: Randomised Set: This patient set included all randomized patients.

Groups in this outcome

Placebo

Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

Nintedanib

Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

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
Placebo	229
Nintedanib	229

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	42.8	Not reported	36.3	49.5	Not reported
Nintedanib	45.0	Not reported	38.4	51.7	Not reported

Source statistical analyses

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

ci Lower Limit
0.76
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.58
estimate Comment
Odds ratio above 1 favours nintedanib.
group Ids
OG000
OG001
non Inferiority Type
OTHER
other Analysis Description
Exact 95% CI by Clopper and Pearson.
p Value
0.3189
p Value Comment
one-sided p-value
param Type
Odds Ratio (OR)
param Value
1.09
statistical Comment
Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.76
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.58
estimate Comment
Odds ratio above 1 favours nintedanib.
group Ids
OG000
OG001
non Inferiority Type
OTHER
other Analysis Description
Exact 95% CI by Clopper and Pearson.
p Value
0.3189
p Value Comment
one-sided p-value
param Type
Odds Ratio (OR)
param Value
1.09
statistical Comment
Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
lower Limit
36.3
upper Limit
49.5
value
42.8
group Id
OG001
lower Limit
38.4
upper Limit
51.7
value
45.0

denoms

counts
group Id
OG000
value
229
group Id
OG001
value
229
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
id
OG000
title
Placebo
description
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
id
OG001
title
Nintedanib

param Type

NUMBER

population Description

Randomised Set: This patient set included all randomized patients.

reporting Status

POSTED

time Frame

Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months

title

Objective Response According to Modified RECIST- Investigator Assessment

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice