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NCT00952289 · FLOW

Participant flow

COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial · Source last updated 2018-03-12

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

groups
  1. description
    Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count \> 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
    id
    FG000
    title
    Ruxolitinib
  2. description
    Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      type
      Disease progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Data lost during site relocation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. comment
        Randomized patients who are documented to have received at least 1 dose of study medication.
        group Id
        FG001
        num Subjects
        151
      type
      Safety Population
    3. achievements
      1. comment
        Represents the number of patients who were still in the study as of 02 November 2010
        group Id
        FG000
        num Subjects
        134
      2. comment
        Includes patients in the study as of 2 November 2010 (78) + those who crossed over to Ruxolitinib.
        group Id
        FG001
        num Subjects
        114
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        40
      type
      NOT COMPLETED
    title
    All Participants
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        19
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Non-compliance to study medication
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      type
      Other Unspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Number of cross over subjects who were still in the study as of 25 JAN 2013
        group Id
        FG001
        num Subjects
        57
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        54
      type
      NOT COMPLETED
    title
    Patients Who Crossed Over to Ruxolitinib
Complete source fields
groups
  1. description
    Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count \> 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
    id
    FG000
    title
    Ruxolitinib
  2. description
    Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      type
      Disease progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Data lost during site relocation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. comment
        Randomized patients who are documented to have received at least 1 dose of study medication.
        group Id
        FG001
        num Subjects
        151
      type
      Safety Population
    3. achievements
      1. comment
        Represents the number of patients who were still in the study as of 02 November 2010
        group Id
        FG000
        num Subjects
        134
      2. comment
        Includes patients in the study as of 2 November 2010 (78) + those who crossed over to Ruxolitinib.
        group Id
        FG001
        num Subjects
        114
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        40
      type
      NOT COMPLETED
    title
    All Participants
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        19
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Non-compliance to study medication
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      type
      Other Unspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Number of cross over subjects who were still in the study as of 25 JAN 2013
        group Id
        FG001
        num Subjects
        57
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        54
      type
      NOT COMPLETED
    title
    Patients Who Crossed Over to Ruxolitinib

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