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NCT05282459 · OUTCOME

Related Adverse Events

Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation · Source last updated 2026-09-03

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

Measure
NUMBER
Unit
Adverse Events
Interval / dispersion
Not reported
Time frame
12 months

What was measured

Toxicity was assessed as the number of related non-serious adverse events and related serious adverse events (SAEs) reported by dose level (Cohort A or Cohort B) for the 12-cycle treatment period plus follow-up.

Groups in this outcome

Enasidenib Mesylat 100mg

Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.

Enasidenib Mesylat 200mg

Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg 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
Enasidenib Mesylat 100mg3
Enasidenib Mesylat 200mg14

Reported measurements

Related Serious Adverse Events
Values in Adverse Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enasidenib Mesylat 100mg0Not reportedNot reportedNot reportedNot reported
Enasidenib Mesylat 200mg0Not reportedNot reportedNot reportedNot reported
Related Non-Serious Adverse Events
Values in Adverse Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enasidenib Mesylat 100mg20Not reportedNot reportedNot reportedNot reported
Enasidenib Mesylat 200mg38Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Related Serious Adverse Events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        38
    title
    Related Non-Serious Adverse Events
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Toxicity was assessed as the number of related non-serious adverse events and related serious adverse events (SAEs) reported by dose level (Cohort A or Cohort B) for the 12-cycle treatment period plus follow-up.
groups
  1. description
    Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
    id
    OG000
    title
    Enasidenib Mesylat 100mg
  2. description
    Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
    id
    OG001
    title
    Enasidenib Mesylat 200mg
param Type
NUMBER
reporting Status
POSTED
time Frame
12 months
title
Related Adverse Events
type
SECONDARY
unit Of Measure
Adverse Events

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice