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NCT04173494 · OUTCOME

Percentage of Participants With Transfusion Independence (TI) at Week 24

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) · Source last updated 2023-11-01

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Week 24

What was measured

TI status was defined as not receiving red blood cell (RBC) or whole blood transfusion for \>=12 weeks, with no hemoglobin (Hgb) level \< 8 grams per deciliter (g/dL) during the same interval. Percentage of participants with TI have been presented.

Analysis population: ITT Analysis Set

Groups in this outcome

MMB 200 mg QD + Placebo

Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.

DAN 300 mg BID + Placebo

Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.

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

Analysis denominator · Participants

GroupSource count
MMB 200 mg QD + Placebo130
DAN 300 mg BID + Placebo65

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MMB 200 mg QD + Placebo30.0Not reported22.2838.66Not reported
DAN 300 mg BID + Placebo20.00Not reported11.1031.77Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    25.30
    estimate Comment
    Non-inferiority difference, defined as p(MMB) - (0.8) \*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.0116
    param Type
    Non-inferiority difference
    param Value
    13.58
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    25.30
    estimate Comment
    Non-inferiority difference, defined as p(MMB) - (0.8) \*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.0116
    param Type
    Non-inferiority difference
    param Value
    13.58
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.28
        upper Limit
        38.66
        value
        30.0
      2. group Id
        OG001
        lower Limit
        11.10
        upper Limit
        31.77
        value
        20.00
denoms
  1. counts
    1. group Id
      OG000
      value
      130
    2. group Id
      OG001
      value
      65
    units
    Participants
description
TI status was defined as not receiving red blood cell (RBC) or whole blood transfusion for \>=12 weeks, with no hemoglobin (Hgb) level \< 8 grams per deciliter (g/dL) during the same interval. Percentage of participants with TI have been presented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.
    id
    OG000
    title
    MMB 200 mg QD + Placebo
  2. description
    Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.
    id
    OG001
    title
    DAN 300 mg BID + Placebo
param Type
NUMBER
population Description
ITT Analysis Set
reporting Status
POSTED
time Frame
Week 24
title
Percentage of Participants With Transfusion Independence (TI) at Week 24
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice