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NCT01445080 · FLOW

Participant flow

Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia · Source last updated 2021-02-02

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

groups
  1. description
    Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.
    id
    FG000
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
  2. description
    Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.
    id
    FG001
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
  3. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    FG002
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
  4. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    FG003
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
  5. description
    Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
    id
    FG004
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
  6. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    FG005
    title
    Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
  7. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    FG006
    title
    Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
  8. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    FG007
    title
    Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
  9. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    FG008
    title
    PK Cohort Expanded: BAY 43-9006 200 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        10
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        6
      type
      Ineligible/Inevaluable
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.
    id
    FG000
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
  2. description
    Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.
    id
    FG001
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
  3. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    FG002
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
  4. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    FG003
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
  5. description
    Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
    id
    FG004
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
  6. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    FG005
    title
    Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
  7. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    FG006
    title
    Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
  8. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    FG007
    title
    Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
  9. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    FG008
    title
    PK Cohort Expanded: BAY 43-9006 200 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        10
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        6
      type
      Ineligible/Inevaluable
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice