NCT01844765 · OUTCOME

Best Complete Cytogenetic Response (CCyR) Categories in Ph+ CML-CP Patients Resistant or Intolerant to Imatinib or Dasatinib - Overall

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: Not reported
Time frame: up to 66 cycles

What was measured

* Complete cytogenetic response (CCyR) - 0% Ph+ metaphases * Partial cytogenetic response (PCyR) - \>0 to 35% Ph+ metaphases * Minor cytogenetic response (mCyR) - \>35 to 65% Ph+ metaphases * Minimal - \>65 to 95% Ph+ metaphases * None - \>95 to 100% Ph+ metaphases * 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

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

Group	Source count
Resistant/Intolerant Ph+ CML in CP	33

Reported measurements

Major cytogenetic response: Complete

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	81.1	Not reported	Not reported	Not reported	Not reported

Major cytogenetic response: Partial

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	3.0	Not reported	Not reported	Not reported	Not reported

Minimal

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	3.0	Not reported	Not reported	Not reported	Not reported

None

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	3.0	Not reported	Not reported	Not reported	Not reported

Missing

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	9.1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
81.1
title
Major cytogenetic response: Complete
categories
measurements
group Id
OG000
value
3.0
title
Major cytogenetic response: Partial
categories
measurements
group Id
OG000
value
3.0
title
Minimal
categories
measurements
group Id
OG000
value
3.0
title
None
categories
measurements
group Id
OG000
value
9.1
title
Missing

denoms

counts
group Id
OG000
value
33
units
Participants

description

groups

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

up to 66 cycles

title

Best Complete Cytogenetic Response (CCyR) Categories in Ph+ CML-CP Patients Resistant or Intolerant to Imatinib or Dasatinib - Overall

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice