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NCT01085630 · FLOW

Participant flow

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy · Source last updated 2021-08-18

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

groups
  1. description
    Patients undergo observation until disease progression.
    id
    FG000
    title
    Arm A (Observation)
  2. description
    Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
    id
    FG001
    title
    Arm B (Pemetrexed)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Insufficient data
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
19 enrolled patients were not randomized for the following reasons: progression during first-line therapy, patient refusal, new disease grade 4 brain tumor, patient expired prior to randomization, insufficient creatinine levels, \> 1 week needed to randomize, prolonged adverse events, ineligible due to ECOG performance status being 2 or 3.
Complete source fields
groups
  1. description
    Patients undergo observation until disease progression.
    id
    FG000
    title
    Arm A (Observation)
  2. description
    Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
    id
    FG001
    title
    Arm B (Pemetrexed)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Insufficient data
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
19 enrolled patients were not randomized for the following reasons: progression during first-line therapy, patient refusal, new disease grade 4 brain tumor, patient expired prior to randomization, insufficient creatinine levels, \> 1 week needed to randomize, prolonged adverse events, ineligible due to ECOG performance status being 2 or 3.

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

Preserved source evidence · Not medical advice