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NCT01915498 · OUTCOME

Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

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 the primary analysis cut-off date of 01 September 2017 to the final analysis cut-off date of 29 July 2019, a maximum of 23 months.

What was measured

A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).

Analysis population: Participants who received at least 1 dose of study treatment during the Safety Follow-up Period.

Groups in this outcome

Safety Follow-up: Enasidenib

Participants remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Safety Follow-up: Enasidenib16

Reported measurements

Any treatment-emergent adverse event (TEAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib16Not reportedNot reportedNot reportedNot reported
TEAE Related to Investigational Product (IP)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib6Not reportedNot reportedNot reportedNot reported
Grade 3-4 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib13Not reportedNot reportedNot reportedNot reported
Grade 3-4 TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib3Not reportedNot reportedNot reportedNot reported
Grade 5 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib0Not reportedNot reportedNot reportedNot reported
Grade 5 TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib0Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib9Not reportedNot reportedNot reportedNot reported
Serious TEAE Related to IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib1Not reportedNot reportedNot reportedNot reported
TEAE Leading to Discontinuation (D/C) of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib0Not reportedNot reportedNot reportedNot reported
TEAE Related to IP Leading to D/C of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib0Not reportedNot reportedNot reportedNot reported
TEAE Leading to Reduction of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib0Not reportedNot reportedNot reportedNot reported
TEAE Related to IP Leading to Reduction of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib0Not reportedNot reportedNot reportedNot reported
TEAE Leading to Interruption of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib4Not reportedNot reportedNot reportedNot reported
TEAE Related to IP Leading to Interruption of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Follow-up: Enasidenib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Any treatment-emergent adverse event (TEAE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    TEAE Related to Investigational Product (IP)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Grade 3-4 TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade 3-4 TEAE Related to IP
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5 TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5 TEAE Related to IP
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Serious TEAE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Serious TEAE Related to IP
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE Leading to Discontinuation (D/C) of IP
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE Related to IP Leading to D/C of IP
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE Leading to Reduction of IP
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE Related to IP Leading to Reduction of IP
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
groups
  1. description
    Participants remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG000
    title
    Safety Follow-up: Enasidenib
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who received at least 1 dose of study treatment during the Safety Follow-up Period.
reporting Status
POSTED
time Frame
From the primary analysis cut-off date of 01 September 2017 to the final analysis cut-off date of 29 July 2019, a maximum of 23 months.
title
Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice