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NCT00934544 · OUTCOME

Bone Marrow Histomorphology

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline, once a year

What was measured

Shift table from baseline to last available postbaseline fibrosis grade by treatment The grade gives an indication of the activity or amount of inflammation and the stage represents the amount of fibrosis or scarring. The grade is assigned a number based on the degree of inflammation, which is usually scored from 0-4 with 0 being no activity and 3 or 4 considered severe activity

Analysis population: Full Analysis Set (FAS) Numbers of Participants Analyzed reflect only those participants who were randomized to either Ruxolitinib or Best Available Therapy and do not count those participants who could have crossed over to Ruxolitinib

Groups in this outcome

Ruxolitinib

5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule

Ruxolitinib - Grade 1

Not reported

Ruxolitinib - Grade 2

Not reported

Ruxolitinib - Grade 3

Not reported

Ruxolitinib - Missing

Not reported

Best Available Therapy (BAT) - Grade 0

Not reported

Best Available Therapy (BAT) - Grade 1

Not reported

Best Available Therapy (BAT) - Grade 2

Not reported

Best Available Therapy (BAT) - Grade 3

Not reported

Best Available Therapy - Missing

Not reported

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ruxolitinib146
Ruxolitinib - Grade 1146
Ruxolitinib - Grade 2146
Ruxolitinib - Grade 3146
Ruxolitinib - Missing146
Best Available Therapy (BAT) - Grade 073
Best Available Therapy (BAT) - Grade 173
Best Available Therapy (BAT) - Grade 273
Best Available Therapy (BAT) - Grade 373
Best Available Therapy - Missing73

Reported measurements

Postbaseline Grade 0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib1Not reported41.82.3Not reported
Ruxolitinib - Grade 11Not reported47.91.9Not reported
Ruxolitinib - Grade 22Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 31Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Missing2Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 00Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 10Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 20Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 30Not reportedNot reportedNot reportedNot reported
Best Available Therapy - Missing0Not reportedNot reportedNot reportedNot reported
Postbaseline Grade 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib0Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 110Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 29Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 32Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Missing0Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 00Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 11Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 20Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 31Not reportedNot reportedNot reportedNot reported
Best Available Therapy - Missing0Not reportedNot reportedNot reportedNot reported
Postbaseline Grade 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib0Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 12Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 28Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 38Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Missing1Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 00Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 10Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 24Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 31Not reportedNot reportedNot reportedNot reported
Best Available Therapy - Missing0Not reportedNot reportedNot reportedNot reported
Postbaseline Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib0Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 16Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 219Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 328Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Missing2Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 00Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 10Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 24Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 38Not reportedNot reportedNot reportedNot reported
Best Available Therapy - Missing3Not reportedNot reportedNot reportedNot reported
Postbaseline Missing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib2Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 12Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 217Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Grade 320Not reportedNot reportedNot reportedNot reported
Ruxolitinib - Missing3Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 02Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 12Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 219Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT) - Grade 324Not reportedNot reportedNot reportedNot reported
Best Available Therapy - Missing4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.8
        upper Limit
        2.3
        value
        1
      2. group Id
        OG001
        lower Limit
        47.9
        upper Limit
        1.9
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
    title
    Postbaseline Grade 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
    title
    Postbaseline Grade 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
    title
    Postbaseline Grade 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        19
      4. group Id
        OG003
        value
        28
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        8
      10. group Id
        OG009
        value
        3
    title
    Postbaseline Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        20
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        19
      9. group Id
        OG008
        value
        24
      10. group Id
        OG009
        value
        4
    title
    Postbaseline Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      146
    2. group Id
      OG001
      value
      146
    3. group Id
      OG002
      value
      146
    4. group Id
      OG003
      value
      146
    5. group Id
      OG004
      value
      146
    6. group Id
      OG005
      value
      73
    7. group Id
      OG006
      value
      73
    8. group Id
      OG007
      value
      73
    9. group Id
      OG008
      value
      73
    10. group Id
      OG009
      value
      73
    units
    Participants
description
Shift table from baseline to last available postbaseline fibrosis grade by treatment The grade gives an indication of the activity or amount of inflammation and the stage represents the amount of fibrosis or scarring. The grade is assigned a number based on the degree of inflammation, which is usually scored from 0-4 with 0 being no activity and 3 or 4 considered severe activity
groups
  1. description
    5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
    id
    OG000
    title
    Ruxolitinib
  2. id
    OG001
    title
    Ruxolitinib - Grade 1
  3. id
    OG002
    title
    Ruxolitinib - Grade 2
  4. id
    OG003
    title
    Ruxolitinib - Grade 3
  5. id
    OG004
    title
    Ruxolitinib - Missing
  6. id
    OG005
    title
    Best Available Therapy (BAT) - Grade 0
  7. id
    OG006
    title
    Best Available Therapy (BAT) - Grade 1
  8. id
    OG007
    title
    Best Available Therapy (BAT) - Grade 2
  9. id
    OG008
    title
    Best Available Therapy (BAT) - Grade 3
  10. id
    OG009
    title
    Best Available Therapy - Missing
param Type
NUMBER
population Description
Full Analysis Set (FAS) Numbers of Participants Analyzed reflect only those participants who were randomized to either Ruxolitinib or Best Available Therapy and do not count those participants who could have crossed over to Ruxolitinib
reporting Status
POSTED
time Frame
Baseline, once a year
title
Bone Marrow Histomorphology
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice