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NCT01883362 · OUTCOME

Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML · Source last updated 2021-03-17

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

Measure
NUMBER
Unit
Proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Randomization to 18 months

What was measured

Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

Groups in this outcome

Standard of Care With Midostaurin

Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).

Standard of Care

Patients received standard of care alone in the post SCT setting

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

Analysis denominator · Participants

GroupSource count
Standard of Care With Midostaurin30
Standard of Care30

Reported measurements

6 months
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin0.93Not reported0.750.98Not reported
Standard of Care0.93Not reported0.740.98Not reported
12 months
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin0.80Not reported0.590.91Not reported
Standard of Care0.93Not reported0.740.98Not reported
18 months
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin0.76Not reported0.540.88Not reported
Standard of Care0.85Not reported0.640.94Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.14
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4297
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.14
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4297
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.75
        upper Limit
        0.98
        value
        0.93
      2. group Id
        OG001
        lower Limit
        0.74
        upper Limit
        0.98
        value
        0.93
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.59
        upper Limit
        0.91
        value
        0.80
      2. group Id
        OG001
        lower Limit
        0.74
        upper Limit
        0.98
        value
        0.93
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.54
        upper Limit
        0.88
        value
        0.76
      2. group Id
        OG001
        lower Limit
        0.64
        upper Limit
        0.94
        value
        0.85
    title
    18 months
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
    id
    OG000
    title
    Standard of Care With Midostaurin
  2. description
    Patients received standard of care alone in the post SCT setting
    id
    OG001
    title
    Standard of Care
param Type
NUMBER
reporting Status
POSTED
time Frame
Randomization to 18 months
title
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
type
SECONDARY
unit Of Measure
Proportion of participants

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

Preserved source evidence · Not medical advice