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NCT01844765 · OUTCOME

Best Complete Hematological Response (CHR) by Time Point

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
cycle 3, 6, 9, 12, 18, 24, 36, 48, 66

What was measured

Complete Hematological Response (CHR) was defined as * WBC count \<10×109/L * platelet count \<450×109/L * basophils \<5% * no blasts and promyelocytes in peripheral blood * myelocytes+metamyelocytes \<5% in peripheral blood * no evidence of extramedullary disease, including spleen and liver * Assessment confirmation after at least 4 weeks for newly diagnosed Ph+ CML-CP

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

Groups in this outcome

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
Newly Diagnosed and Untreated Ph+ CML in First CP25

Reported measurements

by cycle 3
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP76.0Not reported54.990.6Not reported
by cycle 6
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP84.0Not reported63.995.5Not reported
by cycle 9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP88.0Not reported68.897.5Not reported
by cycle 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP92.0Not reported74.099.0Not reported
by cycle 18
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP92.0Not reported74.099.0Not reported
by cycle 24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP92.0Not reported74.099.0Not reported
by cycle 36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP92.0Not reported74.099.0Not reported
by cycle 48
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP92.0Not reported74.099.0Not reported
by cycle 66
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP92.0Not reported74.099.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.9
        upper Limit
        90.6
        value
        76.0
    title
    by cycle 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63.9
        upper Limit
        95.5
        value
        84.0
    title
    by cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 9
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.0
        upper Limit
        99.0
        value
        92.0
    title
    by cycle 12
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.0
        upper Limit
        99.0
        value
        92.0
    title
    by cycle 18
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.0
        upper Limit
        99.0
        value
        92.0
    title
    by cycle 24
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.0
        upper Limit
        99.0
        value
        92.0
    title
    by cycle 36
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.0
        upper Limit
        99.0
        value
        92.0
    title
    by cycle 48
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.0
        upper Limit
        99.0
        value
        92.0
    title
    by cycle 66
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Complete Hematological Response (CHR) was defined as * WBC count \<10×109/L * platelet count \<450×109/L * basophils \<5% * no blasts and promyelocytes in peripheral blood * myelocytes+metamyelocytes \<5% in peripheral blood * no evidence of extramedullary disease, including spleen and liver * Assessment confirmation after at least 4 weeks for newly diagnosed Ph+ CML-CP
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    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
cycle 3, 6, 9, 12, 18, 24, 36, 48, 66
title
Best Complete Hematological Response (CHR) by Time Point
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice