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NCT00952289 · OUTCOME

Overall Survival

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
participants
Interval / dispersion
Not reported
Time frame
From randomization to the data cut-off date (up to 14 months).

What was measured

Overall survival is reported here by the number of deaths from randomization until the data cut-off. 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 data cut. 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

Death events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib10Not reportedNot reportedNot reportedNot reported
Placebo14Not reportedNot reportedNot reportedNot reported
Censored events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib145Not reportedNot reportedNot reportedNot reported
Placebo140Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        14
    title
    Death events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        145
      2. group Id
        OG001
        value
        140
    title
    Censored events
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      154
    units
    Participants
description
Overall survival is reported here by the number of deaths from randomization until the data cut-off. 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 data cut. The survival time was analyzed using the Kaplan-Meier method.
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
From randomization to the data cut-off date (up to 14 months).
title
Overall Survival
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice