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NCT00934544 · OUTCOME

Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis)

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
Percentage of participants
Interval / dispersion
Not reported
Time frame
48 weeks

What was measured

This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used. Fibrosis grades: 0 Scattered linear reticulin with no intersections corresponding to normal bone marrow ; 1 Loose network of reticulin with many intersections, especially in perivascular areas; 2 Diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; 3 Diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis

Analysis population: Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria.

Groups in this outcome

Ruxolitinib

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

Best Available Therapy (BAT)

Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

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
Best Available Therapy (BAT)73

Reported measurements

Grade 0
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib2.7Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT)0.0Not reportedNot reportedNot reportedNot reported
Grade 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib7.5Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT)2.7Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib8.9Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT)6.8Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib24.0Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT)15.1Not reportedNot reportedNot reportedNot reported
Missing Grade
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib56.8Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT)75.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.7
      2. group Id
        OG001
        value
        0.0
    title
    Grade 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7.5
      2. group Id
        OG001
        value
        2.7
    title
    Grade 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8.9
      2. group Id
        OG001
        value
        6.8
    title
    Grade 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        24.0
      2. group Id
        OG001
        value
        15.1
    title
    Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        56.8
      2. group Id
        OG001
        value
        75.3
    title
    Missing Grade
denoms
  1. counts
    1. group Id
      OG000
      value
      146
    2. group Id
      OG001
      value
      73
    units
    Participants
description
This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used. Fibrosis grades: 0 Scattered linear reticulin with no intersections corresponding to normal bone marrow ; 1 Loose network of reticulin with many intersections, especially in perivascular areas; 2 Diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; 3 Diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis
groups
  1. description
    5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
    id
    OG000
    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
    OG001
    title
    Best Available Therapy (BAT)
param Type
NUMBER
population Description
Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria.
reporting Status
POSTED
time Frame
48 weeks
title
Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice