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NCT00952289 · OUTCOME

Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib

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
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).

What was measured

The maintenance of ≥ 35% reduction from Baseline in spleen volume was assessed up until the data cutoff date using the Kaplan-Meier method for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or who subsequently dropped out prior to another assessment.

Analysis population: Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.

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.

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

Analysis denominator · Participants

GroupSource count
Ruxolitinib91

Reported measurements

Still Responder by 48 weeks
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.76Not reported0.660.84Not reported
Still Responder by 96 weeks
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.67Not reported0.550.76Not reported
Still Responder by 144 weeks
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.27Not reported0.020.63Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.66
        upper Limit
        0.84
        value
        0.76
    title
    Still Responder by 48 weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.55
        upper Limit
        0.76
        value
        0.67
    title
    Still Responder by 96 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.02
        upper Limit
        0.63
        value
        0.27
    title
    Still Responder by 144 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    units
    Participants
description
The maintenance of ≥ 35% reduction from Baseline in spleen volume was assessed up until the data cutoff date using the Kaplan-Meier method for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or who subsequently dropped out prior to another assessment.
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
param Type
NUMBER
population Description
Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.
reporting Status
POSTED
time Frame
Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).
title
Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice