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NCT01843374 · OUTCOME

Overall Response Rate by Treatment Arm

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
Percentage
Interval / dispersion
95% Confidence Interval
Time frame
Time from randomization to best response to treatment, assessed up to 3 years.

What was measured

Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.

Analysis population: ITT population

Groups in this outcome

TREMELIMUMAB

Tremelimumab 10mg/kg

PLACEBO

Placebo.

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

Analysis denominator · Participants

GroupSource count
TREMELIMUMAB382
PLACEBO189

Reported measurements

Source class 1
Values in Percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TREMELIMUMAB4.5Not reported2.67.0Not reported
PLACEBO1.1Not reported0.13.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.6
        upper Limit
        7.0
        value
        4.5
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        3.8
        value
        1.1
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      382
    2. group Id
      OG001
      value
      189
    units
    Participants
description
Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
dispersion Type
95% Confidence Interval
groups
  1. description
    Tremelimumab 10mg/kg
    id
    OG000
    title
    TREMELIMUMAB
  2. description
    Placebo.
    id
    OG001
    title
    PLACEBO
param Type
NUMBER
population Description
ITT population
reporting Status
POSTED
time Frame
Time from randomization to best response to treatment, assessed up to 3 years.
title
Overall Response Rate by Treatment Arm
type
SECONDARY
type Units Analyzed
Participants
unit Of Measure
Percentage

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

Preserved source evidence · Not medical advice