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NCT01915498 · OUTCOME

Phase 2 Dose Expansion: Kaplan-Meier Estimate of Overall Survival

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).

What was measured

Overall survival is defined as the time from first dose to the date of death due to any cause. Participants still alive were censored at the last date known to be alive or at the data cut-off date, whichever was earlier.

Analysis population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.

Groups in this outcome

Phase 2: Enasidenib 100 mg QD

Participants received enasidenib 100 mg QD 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
Phase 2: Enasidenib 100 mg QD105

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD7.0Not reported4.98.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.9
        upper Limit
        8.8
        value
        7.0
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
Overall survival is defined as the time from first dose to the date of death due to any cause. Participants still alive were censored at the last date known to be alive or at the data cut-off date, whichever was earlier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG000
    title
    Phase 2: Enasidenib 100 mg QD
param Type
MEDIAN
population Description
All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).
title
Phase 2 Dose Expansion: Kaplan-Meier Estimate of Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice