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NCT01844765 · OUTCOME

MMR Rate by Time Points in Ph+ CML-CP Patients Resistant or Intolerant to Imatinib or Dasatinib

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
95% Confidence Interval
Time frame
By 3, 6, 9 , 12, 24, 36, 48, 66 cycles ( 1 cycle = 28 days)

What was measured

Major molecular response (MMR) was defined as BCR-ABL/ABL % ≤ 0.1% by IS as measured by RQ-PCR, confirmed by duplicate analysis of the same sample.

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

Groups in this outcome

Resistant/Intolerant Ph+ CML in CP

Patients resistant or intolerant to either imatinib or dasatinib

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

Reported measurements

By cycle 3
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP36.4Not reported20.454.9Not reported
By cycle 6
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP45.5Not reported28.163.6Not reported
By cycle 9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP51.5Not reported33.569.2Not reported
By cycle 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
By cycle 18
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
By cycle 24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
By cycle 36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
By cycle 48
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP60.6Not reported42.177.1Not reported
By cycle 66
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP60.6Not reported42.177.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.4
        upper Limit
        54.9
        value
        36.4
    title
    By cycle 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.1
        upper Limit
        63.6
        value
        45.5
    title
    By cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.5
        upper Limit
        69.2
        value
        51.5
    title
    By cycle 9
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
    title
    By cycle 12
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
    title
    By cycle 18
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
    title
    By cycle 24
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
    title
    By cycle 36
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.1
        upper Limit
        77.1
        value
        60.6
    title
    By cycle 48
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.1
        upper Limit
        77.1
        value
        60.6
    title
    By cycle 66
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Major molecular response (MMR) was defined as BCR-ABL/ABL % ≤ 0.1% by IS as measured by RQ-PCR, confirmed by duplicate analysis of the same sample.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    OG000
    title
    Resistant/Intolerant Ph+ CML in 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
By 3, 6, 9 , 12, 24, 36, 48, 66 cycles ( 1 cycle = 28 days)
title
MMR Rate by Time Points in Ph+ CML-CP Patients Resistant or Intolerant to Imatinib or Dasatinib
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice