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NCT01844765 · OUTCOME

Mutational Assessment of BCR-ABL

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
up to 66 cycles

What was measured

Emerging signs of resistance to nilotinib

Analysis population: Full Analysis Set (FAS): All patients who received at least one dose of study medication

Groups in this outcome

Resistant/i Ntolerant 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/i Ntolerant Ph+ CML in CP33
Newly Diagnosed and Untreated Ph+ CML in First CP25

Reported measurements

Patients with >=1 evaluable post-baseline mutational analysis
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/i Ntolerant Ph+ CML in CP39.4Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP32.0Not reportedNot reportedNot reportedNot reported
Patients with any emergent mutation on treatment
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/i Ntolerant Ph+ CML in CP0.0Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP0.0Not reportedNot reportedNot reportedNot reported
Patients with multiple emergent mutations on treatment
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/i Ntolerant Ph+ CML in CP0.0Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        39.4
      2. group Id
        OG001
        value
        32.0
    title
    Patients with >=1 evaluable post-baseline mutational analysis
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    title
    Patients with any emergent mutation on treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    title
    Patients with multiple emergent mutations on treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Emerging signs of resistance to nilotinib
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    OG000
    title
    Resistant/i Ntolerant 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
Full Analysis Set (FAS): All patients who received at least one dose of study medication
reporting Status
POSTED
time Frame
up to 66 cycles
title
Mutational Assessment of BCR-ABL
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice