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NCT01843374 · FLOW

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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.

groups
  1. description
    Placebo.
    id
    FG000
    title
    PLACEBO
  2. description
    TREMELIMUMAB 10 mg/kg
    id
    FG001
    title
    TREMELIMUMAB
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        313
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        20
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        46
      type
      Withdrawing due to Other reason
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        382
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        382
      type
      RANDOMIZED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        379
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 658 patients were screened, 87 patients were excluded from randomisation and 571 patients were randomised: Of the 78 excluded, 66 did not meet inclusion/exclusion criteria; 19 withdrew consent and 2 were excluded for other reasons.
Complete source fields
groups
  1. description
    Placebo.
    id
    FG000
    title
    PLACEBO
  2. description
    TREMELIMUMAB 10 mg/kg
    id
    FG001
    title
    TREMELIMUMAB
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        313
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        20
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        46
      type
      Withdrawing due to Other reason
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        382
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        382
      type
      RANDOMIZED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        379
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 658 patients were screened, 87 patients were excluded from randomisation and 571 patients were randomised: Of the 78 excluded, 66 did not meet inclusion/exclusion criteria; 19 withdrew consent and 2 were excluded for other reasons.

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Preserved source evidence · Not medical advice