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NCT00414076 · FLOW

Participant flow

Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma · Source last updated 2018-11-20

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

groups
  1. description
    Letrozole only
    id
    FG000
    title
    Letrozole
  2. description
    Standard of Care-Patients receive no treatment.
    id
    FG001
    title
    Standard of Care
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
physical exam, vital signs, ECG, laboratory tests, chest x-ray, CT or MRI
recruitment Details
Randomized (adaptive), open-label phase II of Letrozole (experimental) vs. observation (control) in patients with clinical stage I or stage II leiomyosarcoma
Complete source fields
groups
  1. description
    Letrozole only
    id
    FG000
    title
    Letrozole
  2. description
    Standard of Care-Patients receive no treatment.
    id
    FG001
    title
    Standard of Care
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
physical exam, vital signs, ECG, laboratory tests, chest x-ray, CT or MRI
recruitment Details
Randomized (adaptive), open-label phase II of Letrozole (experimental) vs. observation (control) in patients with clinical stage I or stage II leiomyosarcoma

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

Preserved source evidence · Not medical advice