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NCT01969838 · OUTCOME

Splenic Response Rate at Week 24

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Week 24

What was measured

Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.

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

Responder

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Momelotinib (MMB)57Not reportedNot reportedNot reportedNot reported
Ruxolitinib (RUX)64Not reportedNot reportedNot reportedNot reported

Nonresponder

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Momelotinib (MMB)158Not reportedNot reportedNot reportedNot reported
Ruxolitinib (RUX)153Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    To evaluate the noninferiority of MMB over RUX, a conventional 2-sided confidence interval (CI) was calculated for the difference in splenic response rate (SRR) at Week 24: delta = prob(MMB) - 0.6\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared noninferior to RUX in SRR at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is the noninferiority proportion difference.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.014
    param Type
    Proportion Difference - Stratified CMH
    param Value
    0.09
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    0.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    To evaluate the noninferiority of MMB over RUX, a conventional 2-sided confidence interval (CI) was calculated for the difference in splenic response rate (SRR) at Week 24: delta = prob(MMB) - 0.6\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared noninferior to RUX in SRR at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is the noninferiority proportion difference.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.014
    param Type
    Proportion Difference - Stratified CMH
    param Value
    0.09
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        64
      title
      Responder
    2. measurements
      1. group Id
        OG000
        value
        158
      2. group Id
        OG001
        value
        153
      title
      Nonresponder
denoms
  1. counts
    1. group Id
      OG000
      value
      215
    2. group Id
      OG001
      value
      217
    units
    Participants
description
Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Week 24
title
Splenic Response Rate at Week 24
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice