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NCT01844765 · OUTCOME

Growth Data: Abnormal Height Standard Deviation Scores (SDS) Changes by Cohort

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
from first dosing to 66 cycles

What was measured

To assess long term effect on growth, development and maturation of nilotinib treatment in pediatric patients with Ph+ CML in participants with both a baseline and post-baseline value.

Analysis population: Safety Set (SAF): All patients who received at least one dose of study medication in participants with both a baseline and post-baseline value.

Groups in this outcome

Resistant/Intolerant Ph+ CML in CP

Patients resistant or intolerant to either imatinib or dasatinib

Newly Diagnosed and Untreated Ph+ CML in First CP

Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis

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

Analysis denominator · Participants

GroupSource count
Resistant/Intolerant Ph+ CML in CP33
Newly Diagnosed and Untreated Ph+ CML in First CP25

Reported measurements

Decrease from baseline of 1 SDS category (n=32,24)

Analysis denominator · Participants

GroupSource count
Resistant/Intolerant Ph+ CML in CP32
Newly Diagnosed and Untreated Ph+ CML in First CP24
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP27.3Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP32.0Not reportedNot reportedNot reportedNot reported
Decrease from baseline of 2 SDS categories (n=32, 24)

Analysis denominator · Participants

GroupSource count
Resistant/Intolerant Ph+ CML in CP32
Newly Diagnosed and Untreated Ph+ CML in First CP24
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP3.0Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP16.0Not reportedNot reportedNot reportedNot reported
Decrease from baseline of 3 SDS categories(n= 32, 24)

Analysis denominator · Participants

GroupSource count
Resistant/Intolerant Ph+ CML in CP32
Newly Diagnosed and Untreated Ph+ CML in First CP24
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP6.1Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP4.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27.3
      2. group Id
        OG001
        value
        32.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Decrease from baseline of 1 SDS category (n=32,24)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3.0
      2. group Id
        OG001
        value
        16.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Decrease from baseline of 2 SDS categories (n=32, 24)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6.1
      2. group Id
        OG001
        value
        4.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Decrease from baseline of 3 SDS categories(n= 32, 24)
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      25
    units
    Participants
description
To assess long term effect on growth, development and maturation of nilotinib treatment in pediatric patients with Ph+ CML in participants with both a baseline and post-baseline value.
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    OG000
    title
    Resistant/Intolerant Ph+ CML in CP
  2. description
    Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
    id
    OG001
    title
    Newly Diagnosed and Untreated Ph+ CML in First CP
param Type
NUMBER
population Description
Safety Set (SAF): All patients who received at least one dose of study medication in participants with both a baseline and post-baseline value.
reporting Status
POSTED
time Frame
from first dosing to 66 cycles
title
Growth Data: Abnormal Height Standard Deviation Scores (SDS) Changes by Cohort
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice