NCT01844765 · OUTCOME

Long Term Effect of Nilotinib on Bone Metabolism

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: MEAN
Unit: Percentage of participants
Interval / dispersion: Standard Deviation
Time frame: Cycle 66

What was measured

The summary of bone age and Dual-energy X-ray absorptiometry (DEXA) by cohort. Alteration of bone biochemical markers of hand and wrist X-Ray evaluation was observed in bone age standard deviation scores (SDS) and for bone mineral density for DEXA before and after treatment with nilotinib.

Analysis population: Safety Set (SAF): 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

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

Group	Source count
Resistant/Intolerant Ph+ CML in CP	33
Newly Diagnosed and Untreated Ph+ CML in First CP	25

Reported measurements

X-ray (n= 6, 0)

Analysis denominator · Participants

Group	Source count
Resistant/Intolerant Ph+ CML in CP	6
Newly Diagnosed and Untreated Ph+ CML in First CP	0

Values in Percentage of participants · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	-0.61	1.703	Not reported	Not reported	Not reported

DEXA (n = 14, 10)

Analysis denominator · Participants

Group	Source count
Resistant/Intolerant Ph+ CML in CP	14
Newly Diagnosed and Untreated Ph+ CML in First CP	10

Values in Percentage of participants · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	-0.35	1.243	Not reported	Not reported	Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP	-0.70	1.043	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.703
value
-0.61
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
0
units
Participants
title
X-ray (n= 6, 0)
categories
measurements
group Id
OG000
spread
1.243
value
-0.35
group Id
OG001
spread
1.043
value
-0.70
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
10
units
Participants
title
DEXA (n = 14, 10)

denoms

counts
group Id
OG000
value
33
group Id
OG001
value
25
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Patients resistant or intolerant to either imatinib or dasatinib
id
OG000
title
Resistant/Intolerant Ph+ CML in CP
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
OG001
title
Newly Diagnosed and Untreated Ph+ CML in First CP

param Type

MEAN

population Description

Safety Set (SAF): All patients who received at least one dose of study medication.

reporting Status

POSTED

time Frame

Cycle 66

title

Long Term Effect of Nilotinib on Bone Metabolism

type

OTHER_PRE_SPECIFIED

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice