Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02668653 · OUTCOME

Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) · Source last updated 2024-08-06

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
Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment

What was measured

Overall survival is defined as the time from randomization until death from any cause.

Analysis population: Overall survival was assessed in the Intent-to-Treat Analysis Set.

Groups in this outcome

Quizartinib

Participants who were randomized to receive quizartinib treatment regimen.

Placebo

Participants who were randomized to receive placebo treatment regimen.

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

Analysis denominator · Participants

GroupSource count
Quizartinib268
Placebo271

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Quizartinib31.9Not reported21.0NADue to insufficient number of events, an estimate of the upper limit of the confidence interval could not be determined
Placebo15.1Not reported13.226.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.615
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.979
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0324
    param Type
    Hazard Ratio (HR)
    param Value
    0.776
    statistical Comment
    Stratification factors include region, age, and WBC count at the time of diagnosis of AML.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.615
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.979
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0324
    param Type
    Hazard Ratio (HR)
    param Value
    0.776
    statistical Comment
    Stratification factors include region, age, and WBC count at the time of diagnosis of AML.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Due to insufficient number of events, an estimate of the upper limit of the confidence interval could not be determined
        group Id
        OG000
        lower Limit
        21.0
        upper Limit
        NA
        value
        31.9
      2. group Id
        OG001
        lower Limit
        13.2
        upper Limit
        26.2
        value
        15.1
denoms
  1. counts
    1. group Id
      OG000
      value
      268
    2. group Id
      OG001
      value
      271
    units
    Participants
description
Overall survival is defined as the time from randomization until death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who were randomized to receive quizartinib treatment regimen.
    id
    OG000
    title
    Quizartinib
  2. description
    Participants who were randomized to receive placebo treatment regimen.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Overall survival was assessed in the Intent-to-Treat Analysis Set.
reporting Status
POSTED
time Frame
Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment
title
Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice