NCT01907100 · OUTCOME

Overall Survival (OS)

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: MEDIAN
Unit: Months
Interval / dispersion: Inter-Quartile Range
Time frame: From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)

What was measured

Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial.

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	272
Nintedanib	273

Reported measurements

Phase II

Analysis denominator · Participants

Group	Source count
Placebo	43
Nintedanib	44

Values in Months · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Placebo	14.46	Not reported	10.41	NA	The 75th percentile was not reached because of insufficient number of patients with OS event thus not calculated.
Nintedanib	18.30	Not reported	10.91	NA	The 75th percentile was not reached because of insufficient number of patients with OS event thus not calculated.

Phase III

Analysis denominator · Participants

Group	Source count
Placebo	229
Nintedanib	229

Values in Months · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Placebo	16.07	Not reported	9.66	19.29	Not reported
Nintedanib	14.36	Not reported	9.13	18.69	Not reported

Source statistical analyses

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

ci Lower Limit
0.433
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.412
estimate Comment
Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).
group Description
Phase II
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.4132
param Type
Hazard Ratio (HR)
param Value
0.782
statistical Method
Proportional hazards mode
ci Lower Limit
0.79
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.58
estimate Comment
Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.
group Description
Phase III: A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo). If the hazard ratio is below 1 then it favours nintedanib.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.7306
p Value Comment
one-sided p-value
param Type
Hazard Ratio (HR)
param Value
1.12
statistical Method
Proportional hazards model

Complete source fields

analyses

ci Lower Limit
0.433
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.412
estimate Comment
Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).
group Description
Phase II
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.4132
param Type
Hazard Ratio (HR)
param Value
0.782
statistical Method
Proportional hazards mode
ci Lower Limit
0.79
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.58
estimate Comment
Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.
group Description
Phase III: A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo). If the hazard ratio is below 1 then it favours nintedanib.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.7306
p Value Comment
one-sided p-value
param Type
Hazard Ratio (HR)
param Value
1.12
statistical Method
Proportional hazards model

classes

categories
measurements
comment
The 75th percentile was not reached because of insufficient number of patients with OS event thus not calculated.
group Id
OG000
lower Limit
10.41
upper Limit
NA
value
14.46
comment
The 75th percentile was not reached because of insufficient number of patients with OS event thus not calculated.
group Id
OG001
lower Limit
10.91
upper Limit
NA
value
18.30
denoms
counts
group Id
OG000
value
43
group Id
OG001
value
44
units
Participants
title
Phase II
categories
measurements
group Id
OG000
lower Limit
9.66
upper Limit
19.29
value
16.07
group Id
OG001
lower Limit
9.13
upper Limit
18.69
value
14.36
denoms
counts
group Id
OG000
value
229
group Id
OG001
value
229
units
Participants
title
Phase III

denoms

counts
group Id
OG000
value
272
group Id
OG001
value
273
units
Participants

description

Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial.

dispersion Type

Inter-Quartile Range

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

MEDIAN

population Description

Randomised Set: This patient set included all randomized patients.

reporting Status

POSTED

time Frame

From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice