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NCT04173494 · OUTCOME

Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to Week 24

What was measured

An adverse event (AE) is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.

Analysis population: Safety analysis set included all participants in the ITT Analysis set who received at least one dose of study drug.

Groups in this outcome

MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period

Participants were randomized to receive 200 mg of MMB orally QD and a DAN-placebo orally BID during the randomized 24-week double-blind treatment period.

DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period

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.

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 + Placebo- Randomized Double-Blind Treatment Period130
DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period65

Reported measurements

Any non-SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period108Not reportedNot reportedNot reportedNot reported
DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period55Not reportedNot reportedNot reportedNot reported
Any SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period45Not reportedNot reportedNot reportedNot reported
DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period26Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        55
    title
    Any non-SAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        26
    title
    Any SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      130
    2. group Id
      OG001
      value
      65
    units
    Participants
description
An adverse event (AE) is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.
groups
  1. description
    Participants were randomized to receive 200 mg of MMB orally QD and a DAN-placebo orally BID during the randomized 24-week double-blind treatment period.
    id
    OG000
    title
    MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period
  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.
    id
    OG001
    title
    DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants in the ITT Analysis set who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Up to Week 24
title
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice