Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01843374 · OUTCOME

Overall Survival (OS)

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma · Source last updated 2026-07-27

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

Measure
NUMBER
Unit
Number of Participants
Interval / dispersion
Not reported
Time frame
3 years.

What was measured

Overall survival (OS) by treatment arm

Analysis population: ITT population

Groups in this outcome

PLACEBO

Placebo.

TREMELIMUMAB

TREMELIMUMAB 10 mg/kg

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PLACEBO189
TREMELIMUMAB382

Analysis denominator · Participants

GroupSource count
PLACEBO189
TREMELIMUMAB282

Reported measurements

Number of patients with Events (Death)
Values in Number of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PLACEBO154Not reportedNot reportedNot reportedNot reported
TREMELIMUMAB307Not reportedNot reportedNot reportedNot reported
Number patients censored <= 2 weeks before DCO
Values in Number of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PLACEBO25Not reportedNot reportedNot reportedNot reported
TREMELIMUMAB58Not reportedNot reportedNot reportedNot reported
Number of patients censored > 2 weeks before DCO
Values in Number of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PLACEBO10Not reportedNot reportedNot reportedNot reported
TREMELIMUMAB17Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    estimate Comment
    Tremelimumab represents the numerator and Placebo the denominator
    group Description
    H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.4081
    p Value Comment
    P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
    statistical Comment
    The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    estimate Comment
    Tremelimumab represents the numerator and Placebo the denominator
    group Description
    H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.4081
    p Value Comment
    P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
    statistical Comment
    The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        307
    title
    Number of patients with Events (Death)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        58
    title
    Number patients censored <= 2 weeks before DCO
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        17
    title
    Number of patients censored > 2 weeks before DCO
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      382
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      282
    units
    Participants
description
Overall survival (OS) by treatment arm
groups
  1. description
    Placebo.
    id
    OG000
    title
    PLACEBO
  2. description
    TREMELIMUMAB 10 mg/kg
    id
    OG001
    title
    TREMELIMUMAB
param Type
NUMBER
population Description
ITT population
reporting Status
POSTED
time Frame
3 years.
title
Overall Survival (OS)
type
PRIMARY
type Units Analyzed
Participants
unit Of Measure
Number of Participants

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

Preserved source evidence · Not medical advice