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NCT01055314 · FLOW

Participant flow

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma · Source last updated 2017-08-29

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

groups
  1. description
    IMC-A12 + Multi-agent intensive chemotherapy regimen.
    id
    FG000
    title
    IMC-A12
  2. description
    Add temozolomide to vincristine/irinotecan cycles.
    id
    FG001
    title
    Temozolomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        19
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Ineligible
    7. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      type
      Refusal of further protocol therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        75
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        37
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        38
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The number of participants started is 175. Eight patients were declared ineligible by the study chair, and one patient didn't receive treatment.
Complete source fields
groups
  1. description
    IMC-A12 + Multi-agent intensive chemotherapy regimen.
    id
    FG000
    title
    IMC-A12
  2. description
    Add temozolomide to vincristine/irinotecan cycles.
    id
    FG001
    title
    Temozolomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        19
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Ineligible
    7. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      type
      Refusal of further protocol therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        75
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        37
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        38
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The number of participants started is 175. Eight patients were declared ineligible by the study chair, and one patient didn't receive treatment.

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Preserved source evidence · Not medical advice