NCT04173494 · OUTCOME

Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks

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: Up to 24 weeks

What was measured

Percentage of participants with zero RBC units transfused over 24-weeks were reported.

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

Group	Source count
MMB 200 mg QD + Placebo	130
DAN 300 mg BID + Placebo	65

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
MMB 200 mg QD + Placebo	35.38	Not reported	27.20	44.25	Not reported
DAN 300 mg BID + Placebo	16.92	Not reported	8.76	28.27	Not reported

Source statistical analyses

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

ci Lower Limit
7.99
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
26.40
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.0012
param Type
Stratified Cochran-Mantel-Haenszel
param Value
17.20
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
7.99
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
26.40
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.0012
param Type
Stratified Cochran-Mantel-Haenszel
param Value
17.20
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
lower Limit
27.20
upper Limit
44.25
value
35.38
group Id
OG001
lower Limit
8.76
upper Limit
28.27
value
16.92

denoms

counts
group Id
OG000
value
130
group Id
OG001
value
65
units
Participants

description

Percentage of participants with zero RBC units transfused over 24-weeks were reported.

dispersion Type

95% Confidence Interval

groups

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
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

Up to 24 weeks

title

Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice