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NCT02339740 · OUTCOME

EFS in High Risk APL Patients

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia · Source last updated 2026-02-18

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Up to 24 months

What was measured

EFS is defined as the time from on study to failure to achieve hematological CR prior to start of consolidation, persistence of molecular positive disease after MRD positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits.

Analysis population: Patients ineligible, did not start treatment, or RQPCR positive not confirmed are excluded from analyses of EFS

Groups in this outcome

High Risk

WBC ≥10,000 cells/µL

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

Analysis denominator · Participants

GroupSource count
High Risk56

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
High Risk96.1Not reported88.298.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        88.2
        upper Limit
        98.8
        value
        96.1
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    units
    Participants
description
EFS is defined as the time from on study to failure to achieve hematological CR prior to start of consolidation, persistence of molecular positive disease after MRD positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits.
dispersion Type
90% Confidence Interval
groups
  1. description
    WBC ≥10,000 cells/µL
    id
    OG000
    title
    High Risk
param Type
NUMBER
population Description
Patients ineligible, did not start treatment, or RQPCR positive not confirmed are excluded from analyses of EFS
reporting Status
POSTED
time Frame
Up to 24 months
title
EFS in High Risk APL Patients
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice