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NCT00866281 · OUTCOME

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs or SAEs and Death During the Study

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline (start of study treatment) up to End of treatment (up to 24 months after last dose or until death whichever occurred first)

What was measured

An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. On treatment death was a fatal event leading to permanent cessations of all vital functions of the body.

Analysis population: The analysis was performed in safety set population, defined as the participants who received at least one dose of midostaurin.

Groups in this outcome

Cohort 1: Midostaurin (30 Milligrams/Meters^2)

Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m\^2 bid through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2.

Cohort 2: Midostaurin (60 mg/m^2)

Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 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
Cohort 1: Midostaurin (30 Milligrams/Meters^2)7
Cohort 2: Midostaurin (60 mg/m^2)15

Reported measurements

AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Midostaurin (30 Milligrams/Meters^2)6Not reportedNot reportedNot reportedNot reported
Cohort 2: Midostaurin (60 mg/m^2)15Not reportedNot reportedNot reportedNot reported
AEs suspected to be drug related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Midostaurin (30 Milligrams/Meters^2)1Not reportedNot reportedNot reportedNot reported
Cohort 2: Midostaurin (60 mg/m^2)2Not reportedNot reportedNot reportedNot reported
On-treatment death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Midostaurin (30 Milligrams/Meters^2)2Not reportedNot reportedNot reportedNot reported
Cohort 2: Midostaurin (60 mg/m^2)3Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Midostaurin (30 Milligrams/Meters^2)3Not reportedNot reportedNot reportedNot reported
Cohort 2: Midostaurin (60 mg/m^2)6Not reportedNot reportedNot reportedNot reported
SAEs suspected to be drug related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Midostaurin (30 Milligrams/Meters^2)0Not reportedNot reportedNot reportedNot reported
Cohort 2: Midostaurin (60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        15
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    AEs suspected to be drug related
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    On-treatment death
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
    title
    SAEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    SAEs suspected to be drug related
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      15
    units
    Participants
description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. On treatment death was a fatal event leading to permanent cessations of all vital functions of the body.
groups
  1. description
    Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m\^2 bid through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2.
    id
    OG000
    title
    Cohort 1: Midostaurin (30 Milligrams/Meters^2)
  2. description
    Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 mg/m\^2.
    id
    OG001
    title
    Cohort 2: Midostaurin (60 mg/m^2)
param Type
NUMBER
population Description
The analysis was performed in safety set population, defined as the participants who received at least one dose of midostaurin.
reporting Status
POSTED
time Frame
Baseline (start of study treatment) up to End of treatment (up to 24 months after last dose or until death whichever occurred first)
title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs or SAEs and Death During the Study
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice