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NCT01969838 · OUTCOME

Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding)

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis · Source last updated 2023-05-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
units/month
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline to Week 24

What was measured

Rate of RBC transfusion was defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the double-blind phase.

Groups in this outcome

Momelotinib (MMB)

Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.

Ruxolitinib (RUX)

Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once 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
Momelotinib (MMB)215
Ruxolitinib (RUX)217

Reported measurements

Source class 1
Values in units/month · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Momelotinib (MMB)0.0Not reported0.00.2Not reported
Ruxolitinib (RUX)0.4Not reported0.01.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.43
    estimate Comment
    A smaller ratio represents larger benefit.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Rate ratio
    param Value
    0.28
    statistical Method
    Negative Binomial Model, Adjusted
Complete source fields
analyses
  1. ci Lower Limit
    0.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.43
    estimate Comment
    A smaller ratio represents larger benefit.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Rate ratio
    param Value
    0.28
    statistical Method
    Negative Binomial Model, Adjusted
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.2
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        1.5
        value
        0.4
denoms
  1. counts
    1. group Id
      OG000
      value
      215
    2. group Id
      OG001
      value
      217
    units
    Participants
description
Rate of RBC transfusion was defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the double-blind phase.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
    id
    OG000
    title
    Momelotinib (MMB)
  2. description
    Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
    id
    OG001
    title
    Ruxolitinib (RUX)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Baseline to Week 24
title
Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding)
type
SECONDARY
unit Of Measure
units/month

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

Preserved source evidence · Not medical advice