NCT03710876 · OUTCOME

Survival Rate at 30 Months

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma · Source last updated 2026-04-21

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

Measure: NUMBER
Unit: Percentage of survivors
Interval / dispersion: 95% Confidence Interval
Time frame: 30 months

What was measured

Proportion surviving at 30 months

Analysis population: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).

Groups in this outcome

Treatment Group

rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

Control Group

Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

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 Group	27
Control Group	22

Reported measurements

Source class 1

Values in Percentage of survivors · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	33.3	Not reported	16.8	50.9	Not reported
Control Group	19.8	Not reported	6.3	38.9	Not reported

Source statistical analyses

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

ci Lower Limit
-11.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
38.3
estimate Comment
Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.
group Description
Percentage proportion calculated by Kaplan-Meier method.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2856
p Value Comment
2-sided
param Type
Risk Difference (RD)
param Value
13.5
statistical Comment
Variance calculated by Greenwood's method.
statistical Method
Chi-squared

Complete source fields

analyses

ci Lower Limit
-11.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
38.3
estimate Comment
Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.
group Description
Percentage proportion calculated by Kaplan-Meier method.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2856
p Value Comment
2-sided
param Type
Risk Difference (RD)
param Value
13.5
statistical Comment
Variance calculated by Greenwood's method.
statistical Method
Chi-squared

classes

categories
measurements
group Id
OG000
lower Limit
16.8
upper Limit
50.9
value
33.3
group Id
OG001
lower Limit
6.3
upper Limit
38.9
value
19.8

denoms

counts
group Id
OG000
value
27
group Id
OG001
value
22
units
Participants

description

Proportion surviving at 30 months

dispersion Type

95% Confidence Interval

groups

description
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
id
OG000
title
Treatment Group
description
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
id
OG001
title
Control Group

param Type

NUMBER

population Description

The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).

reporting Status

POSTED

time Frame

30 months

title

Survival Rate at 30 Months

type

OTHER_PRE_SPECIFIED

unit Of Measure

Percentage of survivors

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

Preserved source evidence · Not medical advice