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NCT00952289 · OUTCOME

Overall Survival Time at Week 144

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.

Measure
NUMBER
Unit
probability
Interval / dispersion
95% Confidence Interval
Time frame
Week 144

What was measured

Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.

Analysis population: ITT population

Groups in this outcome

Ruxolitinib

Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.

Placebo

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.

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

Analysis denominator · Participants

GroupSource count
Ruxolitinib155
Placebo154

Reported measurements

Source class 1
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.74Not reported0.660.81Not reported
Placebo0.61Not reported0.530.69Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.66
        upper Limit
        0.81
        value
        0.74
      2. group Id
        OG001
        lower Limit
        0.53
        upper Limit
        0.69
        value
        0.61
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      154
    units
    Participants
description
Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
    id
    OG000
    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
    OG001
    title
    Placebo
param Type
NUMBER
population Description
ITT population
reporting Status
POSTED
time Frame
Week 144
title
Overall Survival Time at Week 144
type
SECONDARY
unit Of Measure
probability

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

Preserved source evidence · Not medical advice