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NCT04173494 · OUTCOME

Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Week 24 to a maximum of 151 weeks

What was measured

An 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

Groups in this outcome

MMB 200 mg QD- Open-Label Extended 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.

DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended 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- Open-Label Extended Treatment Period93
DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period41

Reported measurements

Any non-SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MMB 200 mg QD- Open-Label Extended Treatment Period57Not reportedNot reportedNot reportedNot reported
DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period28Not reportedNot reportedNot reportedNot reported
Any SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MMB 200 mg QD- Open-Label Extended Treatment Period30Not reportedNot reportedNot reportedNot reported
DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        28
    title
    Any non-SAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        12
    title
    Any SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    2. group Id
      OG001
      value
      41
    units
    Participants
description
An 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 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.
    id
    OG000
    title
    MMB 200 mg QD- Open-Label Extended Treatment Period
  2. description
    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 to MMB 200 mg QD- Open-Label Extended Treatment Period
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set
reporting Status
POSTED
time Frame
From Week 24 to a maximum of 151 weeks
title
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 Weeks
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice