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NCT00934544 · OUTCOME

Progression-free Survival (PFS)

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
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
Time from randomization and the earliest of either increase in spleen volume >=25% from on-study nadir, splenic irradiation, splenectomy, leukemic transformation or death

What was measured

Median of time progression free survival (95% CI), years

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. Treatment groups were defined according to the treatment assignment at the time of randomization.

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

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib1.6Not reported1.22.3Not reported
Best Available Therapy (BAT)1.4Not reported1.11.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        2.3
        value
        1.6
      2. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        1.9
        value
        1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      146
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Median of time progression free survival (95% CI), years
dispersion Type
95% Confidence Interval
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
MEDIAN
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. Treatment groups were defined according to the treatment assignment at the time of randomization.
reporting Status
POSTED
time Frame
Time from randomization and the earliest of either increase in spleen volume >=25% from on-study nadir, splenic irradiation, splenectomy, leukemic transformation or death
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice