Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01844765 · OUTCOME

Best Major Cytogenetic Response (MCyR) Rate by Time Point in Newly Diagnosed Ph+ CML Patients

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
6, 12, 18, 24, 36, 48, 66 cycles

What was measured

Major cytogenetic response (MCyR) - 0 to 35% Ph+ metaphases. A major response combines both complete and partial responses.

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 6
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 CP88.0Not reported68.897.5Not reported
by cycle 18
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 24
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 36
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 48
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 66
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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 12
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 18
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 24
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 36
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 48
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
    title
    by cycle 66
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Major cytogenetic response (MCyR) - 0 to 35% Ph+ metaphases. A major response combines both complete and partial responses.
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
6, 12, 18, 24, 36, 48, 66 cycles
title
Best Major Cytogenetic Response (MCyR) Rate by Time Point in Newly Diagnosed Ph+ CML Patients
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice