Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01844765 · OUTCOME

Time to First MMR Among Newly Diagnosed Ph+ CML-CP Patients Who Achieved MMR

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 the first MMR within 66 cycles period

What was measured

Time to MMR is the time from first study drug intake to first major molecular response computed only for participants who achieved MMR.

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 CP19

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP5.59Not reported5.5210.84Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.52
        upper Limit
        10.84
        value
        5.59
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Time to MMR is the time from first study drug intake to first major molecular response computed only for participants who achieved MMR.
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 the first MMR within 66 cycles period
title
Time to First MMR Among Newly Diagnosed Ph+ CML-CP Patients Who Achieved MMR
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice