NCT02899299 · OUTCOME

Overall Survival (OS)

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients · Source last updated 2024-05-21

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 randomization to the date of death (Up to 40 Months)

What was measured

Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.

Analysis population: All Randomized Participants

Groups in this outcome

Treatment A

Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W

Treatment B

Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC 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
Treatment A	303
Treatment B	302

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment A	18.07	Not reported	16.82	21.45	Not reported
Treatment B	14.09	Not reported	12.45	16.23	Not reported

Source statistical analyses

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

ci Lower Limit
0.60
ci Num Sides
TWO_SIDED
ci Pct Value
96.6
ci Upper Limit
0.91
estimate Comment
Stratified Cox proportional hazard model
group Ids
OG000
OG001
non Inferiority Comment
Treatment A over Treatment B
non Inferiority Type
SUPERIORITY
p Value
0.0020
p Value Comment
Boundary for statistical significance was a p-value \< 0.0345
param Type
Hazard Ratio (HR)
param Value
0.74
statistical Comment
This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT
statistical Method
Stratified Log Rank

Complete source fields

analyses

ci Lower Limit
0.60
ci Num Sides
TWO_SIDED
ci Pct Value
96.6
ci Upper Limit
0.91
estimate Comment
Stratified Cox proportional hazard model
group Ids
OG000
OG001
non Inferiority Comment
Treatment A over Treatment B
non Inferiority Type
SUPERIORITY
p Value
0.0020
p Value Comment
Boundary for statistical significance was a p-value \< 0.0345
param Type
Hazard Ratio (HR)
param Value
0.74
statistical Comment
This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT
statistical Method
Stratified Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
16.82
upper Limit
21.45
value
18.07
group Id
OG001
lower Limit
12.45
upper Limit
16.23
value
14.09

denoms

counts
group Id
OG000
value
303
group Id
OG001
value
302
units
Participants

description

Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.

dispersion Type

95% Confidence Interval

groups

description
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
id
OG000
title
Treatment A
description
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
id
OG001
title
Treatment B

param Type

MEDIAN

population Description

All Randomized Participants

reporting Status

POSTED

time Frame

From randomization to the date of death (Up to 40 Months)

title

Overall Survival (OS)

type

PRIMARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice