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NCT00866281 · OUTCOME

Overall Survival With Midostaurin

A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia · Source last updated 2015-12-22

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
Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)

What was measured

Overall survival (OS) was defined as the time from start of treatment to date of death due to any cause. The percentage (%) event-free probability estimates were obtained from the Kaplan-Meier survival estimates.

Analysis population: The analysis was performed in FAS population.

Groups in this outcome

AML Subjects

Subjects with acute myeloid leukemia (AML) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.

MLLr-ALL Subjects

Subjects with mixed lineage leukemia gene- rearranged acute lymphoblastic leukemia (MLLr-ALL) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.

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

Analysis denominator · Participants

GroupSource count
AML Subjects9
MLLr-ALL Subjects13

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AML Subjects3.68Not reported2.7278.312Not reported
MLLr-ALL Subjects1.35Not reported0.9532.924Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.727
        upper Limit
        8.312
        value
        3.68
      2. group Id
        OG001
        lower Limit
        0.953
        upper Limit
        2.924
        value
        1.35
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Overall survival (OS) was defined as the time from start of treatment to date of death due to any cause. The percentage (%) event-free probability estimates were obtained from the Kaplan-Meier survival estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects with acute myeloid leukemia (AML) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.
    id
    OG000
    title
    AML Subjects
  2. description
    Subjects with mixed lineage leukemia gene- rearranged acute lymphoblastic leukemia (MLLr-ALL) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.
    id
    OG001
    title
    MLLr-ALL Subjects
param Type
MEDIAN
population Description
The analysis was performed in FAS population.
reporting Status
POSTED
time Frame
Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)
title
Overall Survival With Midostaurin
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice