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NCT01844765 · OUTCOME

Summary of Time to First Complete Hematological Response (CHR) Among Patients Who Achieved Confirmed CHR in Newly Diagnosed CML-CP 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
from first dosing to CHR, UP TO 66 CYCLES

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 CP23

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP0.95Not reported0.722.76Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        2.76
        value
        0.95
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    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
MEDIAN
population Description
Full Analysis Set (FAS): All patients who received at least one dose of study medication
reporting Status
POSTED
time Frame
from first dosing to CHR, UP TO 66 CYCLES
title
Summary of Time to First Complete Hematological Response (CHR) Among Patients Who Achieved Confirmed CHR in Newly Diagnosed CML-CP Patients
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice