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NCT01883362 · OUTCOME

All Collected Deaths

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
Participants
Interval / dispersion
Not reported
Time frame
approx. 12.5 months, approx. 51 months

What was measured

On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months). Deaths post treatment survival follow up were collected after the on treatment period, up to approximately 51 months.

Analysis population: Clinical Database Population: all treated patients

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

Total Deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin8Not reportedNot reportedNot reportedNot reported
Standard of Care4Not reportedNot reportedNot reportedNot reported
Deaths on-treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care With Midostaurin1Not reportedNot reportedNot reportedNot reported
Standard of Care0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        4
    title
    Total Deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Deaths on-treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      30
    units
    Participants
description
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months). Deaths post treatment survival follow up were collected after the on treatment period, up to approximately 51 months.
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
population Description
Clinical Database Population: all treated patients
reporting Status
POSTED
time Frame
approx. 12.5 months, approx. 51 months
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice