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NCT01883362 · OUTCOME

Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 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
date of transplant up to 24 months

What was measured

Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease

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 Midostaurin0.96Not reported0.770.99Not reported
Standard of Care1.00Not reported1.001.00Not reported
12 months
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin0.96Not reported0.770.99Not reported
Standard of Care0.96Not reported0.760.99Not reported
18 months
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin0.92Not reported0.710.98Not reported
Standard of Care0.96Not reported0.760.99Not reported
24 months
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin0.92Not reported0.710.98Not reported
Standard of Care0.96Not reported0.760.99Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.74
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4169
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.74
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4169
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.77
        upper Limit
        0.99
        value
        0.96
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        1.00
        value
        1.00
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.77
        upper Limit
        0.99
        value
        0.96
      2. group Id
        OG001
        lower Limit
        0.76
        upper Limit
        0.99
        value
        0.96
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.71
        upper Limit
        0.98
        value
        0.92
      2. group Id
        OG001
        lower Limit
        0.76
        upper Limit
        0.99
        value
        0.96
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.71
        upper Limit
        0.98
        value
        0.92
      2. group Id
        OG001
        lower Limit
        0.76
        upper Limit
        0.99
        value
        0.96
    title
    24 months
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease
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
date of transplant up to 24 months
title
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
type
SECONDARY
unit Of Measure
proportion of participants

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Preserved source evidence · Not medical advice