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NCT00934544 · FLOW

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Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial · Source last updated 2019-08-19

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

groups
  1. description
    5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
    id
    FG000
    title
    Ruxolitinib
  2. description
    Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
    id
    FG001
    title
    Best Available Therapy (BAT)
  3. description
    5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
    id
    FG002
    title
    Ruxolitinib After BAT (Cross-over)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Non-compliance with study Medication
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Non-compliance with study procedures
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Other reasons
    8. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        0
      type
      Entered extension phase
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        146
      2. group Id
        FG001
        num Subjects
        73
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Primary Endpoint Analysis (Interim)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        6
      type
      Including stem cell transplantation
    2. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        10
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Noncompliance with study medication
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Noncompliance with study procedures
    8. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        146
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        27
      type
      Crossed Over After Qualifying Event
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Crossed Over After AMEND 5
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      Crossed Over: Other
    5. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Disposition at 5 Year Follow-up
pre Assignment Details
219 unique participants were randomized to either ruxolitinib or BAT. Of the 73 participants randomized to BAT, 45 were crossed over to ruxolitinib after a protocol-specified qualifying disease progression event.
recruitment Details
Subjects were recruited from 9 countries located in Europe: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom.
Complete source fields
groups
  1. description
    5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
    id
    FG000
    title
    Ruxolitinib
  2. description
    Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
    id
    FG001
    title
    Best Available Therapy (BAT)
  3. description
    5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
    id
    FG002
    title
    Ruxolitinib After BAT (Cross-over)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Non-compliance with study Medication
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Non-compliance with study procedures
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Other reasons
    8. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        0
      type
      Entered extension phase
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        146
      2. group Id
        FG001
        num Subjects
        73
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Primary Endpoint Analysis (Interim)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        6
      type
      Including stem cell transplantation
    2. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        10
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Noncompliance with study medication
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Noncompliance with study procedures
    8. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        146
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        27
      type
      Crossed Over After Qualifying Event
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Crossed Over After AMEND 5
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      Crossed Over: Other
    5. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Disposition at 5 Year Follow-up
pre Assignment Details
219 unique participants were randomized to either ruxolitinib or BAT. Of the 73 participants randomized to BAT, 45 were crossed over to ruxolitinib after a protocol-specified qualifying disease progression event.
recruitment Details
Subjects were recruited from 9 countries located in Europe: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice