BCR-ABL Ratio (%) Over Time in Nilotinib Treatment Re-initiation Phase (NTRI)
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients · Source last updated 2026-08-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
Percent
Interval / dispersion
Standard Deviation
Time frame
Baseline; every 4 weeks up to Week 24; and every 12 weeks thereafter, up to Week 528
What was measured
The BCR-ABL ratio (%) represents the level of BCR-ABL fusion gene transcripts relative to a control gene (ABL) measured in peripheral blood samples using quantitative reverse transcription polymerase chain reaction (RT-PCR). Results are expressed as a percentage on the International Scale (IS), a standardized reporting method that allows comparison across laboratories. The BCR-ABL ratio is used to assess the molecular response to treatment, with lower values indicating a reduced disease burden.
Analysis population: The nilotinib treatment re-initiation (NTRI) safety set included all participants who received at least one dose of study medication during the nilotinib treatment re-initiation phase.
Groups in this outcome
NTRI Phase
Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.
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
NTRI Phase
91
Reported measurements
Baseline
Analysis denominator · Participants
Group
Source count
NTRI Phase
91
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.22697
0.194306
Not reported
Not reported
Not reported
Week 4
Analysis denominator · Participants
Group
Source count
NTRI Phase
90
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.43848
1.302378
Not reported
Not reported
Not reported
Week 8
Analysis denominator · Participants
Group
Source count
NTRI Phase
85
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.14038
0.527741
Not reported
Not reported
Not reported
Week 12
Analysis denominator · Participants
Group
Source count
NTRI Phase
86
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.03205
0.172524
Not reported
Not reported
Not reported
Week 16
Analysis denominator · Participants
Group
Source count
NTRI Phase
84
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01044
0.055724
Not reported
Not reported
Not reported
Week 20
Analysis denominator · Participants
Group
Source count
NTRI Phase
84
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00476
0.027446
Not reported
Not reported
Not reported
Week 24
Analysis denominator · Participants
Group
Source count
NTRI Phase
83
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00291
0.011041
Not reported
Not reported
Not reported
Week 36
Analysis denominator · Participants
Group
Source count
NTRI Phase
80
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00209
0.010182
Not reported
Not reported
Not reported
Week 48
Analysis denominator · Participants
Group
Source count
NTRI Phase
78
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00149
0.007022
Not reported
Not reported
Not reported
Week 60
Analysis denominator · Participants
Group
Source count
NTRI Phase
76
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00120
0.006373
Not reported
Not reported
Not reported
Week 72
Analysis denominator · Participants
Group
Source count
NTRI Phase
73
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00098
0.003366
Not reported
Not reported
Not reported
Week 84
Analysis denominator · Participants
Group
Source count
NTRI Phase
70
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00120
0.006416
Not reported
Not reported
Not reported
Week 96
Analysis denominator · Participants
Group
Source count
NTRI Phase
69
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00169
0.010148
Not reported
Not reported
Not reported
Week 108
Analysis denominator · Participants
Group
Source count
NTRI Phase
70
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00492
0.032543
Not reported
Not reported
Not reported
Week 120
Analysis denominator · Participants
Group
Source count
NTRI Phase
65
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00073
0.002945
Not reported
Not reported
Not reported
Week 132
Analysis denominator · Participants
Group
Source count
NTRI Phase
65
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00055
0.002217
Not reported
Not reported
Not reported
Week 144
Analysis denominator · Participants
Group
Source count
NTRI Phase
60
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00068
0.002429
Not reported
Not reported
Not reported
Week 156
Analysis denominator · Participants
Group
Source count
NTRI Phase
61
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00074
0.003559
Not reported
Not reported
Not reported
Week 168
Analysis denominator · Participants
Group
Source count
NTRI Phase
58
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00071
0.003267
Not reported
Not reported
Not reported
Week 180
Analysis denominator · Participants
Group
Source count
NTRI Phase
54
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00047
0.001156
Not reported
Not reported
Not reported
Week 192
Analysis denominator · Participants
Group
Source count
NTRI Phase
54
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00262
0.016285
Not reported
Not reported
Not reported
Week 204
Analysis denominator · Participants
Group
Source count
NTRI Phase
53
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01753
0.126293
Not reported
Not reported
Not reported
Week 216
Analysis denominator · Participants
Group
Source count
NTRI Phase
54
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00683
0.048460
Not reported
Not reported
Not reported
Week 228
Analysis denominator · Participants
Group
Source count
NTRI Phase
50
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00427
0.029012
Not reported
Not reported
Not reported
Week 240
Analysis denominator · Participants
Group
Source count
NTRI Phase
45
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00315
0.016585
Not reported
Not reported
Not reported
Week 252
Analysis denominator · Participants
Group
Source count
NTRI Phase
43
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00660
0.029570
Not reported
Not reported
Not reported
Week 264
Analysis denominator · Participants
Group
Source count
NTRI Phase
38
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01436
0.061134
Not reported
Not reported
Not reported
Week 276
Analysis denominator · Participants
Group
Source count
NTRI Phase
41
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01784
0.081702
Not reported
Not reported
Not reported
Week 288
Analysis denominator · Participants
Group
Source count
NTRI Phase
38
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01616
0.098699
Not reported
Not reported
Not reported
Week 300
Analysis denominator · Participants
Group
Source count
NTRI Phase
38
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01865
0.113939
Not reported
Not reported
Not reported
Week 312
Analysis denominator · Participants
Group
Source count
NTRI Phase
35
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.02516
0.124114
Not reported
Not reported
Not reported
Week 324
Analysis denominator · Participants
Group
Source count
NTRI Phase
35
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01939
0.113715
Not reported
Not reported
Not reported
Week 336
Analysis denominator · Participants
Group
Source count
NTRI Phase
35
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01348
0.078374
Not reported
Not reported
Not reported
Week 348
Analysis denominator · Participants
Group
Source count
NTRI Phase
34
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00801
0.045810
Not reported
Not reported
Not reported
Week 360
Analysis denominator · Participants
Group
Source count
NTRI Phase
33
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.01015
0.057496
Not reported
Not reported
Not reported
Week 372
Analysis denominator · Participants
Group
Source count
NTRI Phase
33
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00509
0.028312
Not reported
Not reported
Not reported
Week 384
Analysis denominator · Participants
Group
Source count
NTRI Phase
32
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00206
0.010247
Not reported
Not reported
Not reported
Week 396
Analysis denominator · Participants
Group
Source count
NTRI Phase
30
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00137
0.006892
Not reported
Not reported
Not reported
Week 408
Analysis denominator · Participants
Group
Source count
NTRI Phase
27
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00158
0.007350
Not reported
Not reported
Not reported
Week 420
Analysis denominator · Participants
Group
Source count
NTRI Phase
29
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00171
0.008446
Not reported
Not reported
Not reported
Week 432
Analysis denominator · Participants
Group
Source count
NTRI Phase
29
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00102
0.004642
Not reported
Not reported
Not reported
Week 444
Analysis denominator · Participants
Group
Source count
NTRI Phase
25
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00057
0.002430
Not reported
Not reported
Not reported
Week 456
Analysis denominator · Participants
Group
Source count
NTRI Phase
26
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00084
0.002877
Not reported
Not reported
Not reported
Week 468
Analysis denominator · Participants
Group
Source count
NTRI Phase
25
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00083
0.003204
Not reported
Not reported
Not reported
Week 480
Analysis denominator · Participants
Group
Source count
NTRI Phase
22
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.03371
0.156501
Not reported
Not reported
Not reported
Week 492
Analysis denominator · Participants
Group
Source count
NTRI Phase
22
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00062
0.002046
Not reported
Not reported
Not reported
Week 504
Analysis denominator · Participants
Group
Source count
NTRI Phase
17
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00044
0.001246
Not reported
Not reported
Not reported
Week 516
Analysis denominator · Participants
Group
Source count
NTRI Phase
9
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00073
0.001920
Not reported
Not reported
Not reported
Week 528
Analysis denominator · Participants
Group
Source count
NTRI Phase
1
Values in Percent · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
NTRI Phase
0.00000
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
0.194306
value
0.22697
denoms
counts
group Id
OG000
value
91
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
1.302378
value
0.43848
denoms
counts
group Id
OG000
value
90
units
Participants
title
Week 4
categories
measurements
group Id
OG000
spread
0.527741
value
0.14038
denoms
counts
group Id
OG000
value
85
units
Participants
title
Week 8
categories
measurements
group Id
OG000
spread
0.172524
value
0.03205
denoms
counts
group Id
OG000
value
86
units
Participants
title
Week 12
categories
measurements
group Id
OG000
spread
0.055724
value
0.01044
denoms
counts
group Id
OG000
value
84
units
Participants
title
Week 16
categories
measurements
group Id
OG000
spread
0.027446
value
0.00476
denoms
counts
group Id
OG000
value
84
units
Participants
title
Week 20
categories
measurements
group Id
OG000
spread
0.011041
value
0.00291
denoms
counts
group Id
OG000
value
83
units
Participants
title
Week 24
categories
measurements
group Id
OG000
spread
0.010182
value
0.00209
denoms
counts
group Id
OG000
value
80
units
Participants
title
Week 36
categories
measurements
group Id
OG000
spread
0.007022
value
0.00149
denoms
counts
group Id
OG000
value
78
units
Participants
title
Week 48
categories
measurements
group Id
OG000
spread
0.006373
value
0.00120
denoms
counts
group Id
OG000
value
76
units
Participants
title
Week 60
categories
measurements
group Id
OG000
spread
0.003366
value
0.00098
denoms
counts
group Id
OG000
value
73
units
Participants
title
Week 72
categories
measurements
group Id
OG000
spread
0.006416
value
0.00120
denoms
counts
group Id
OG000
value
70
units
Participants
title
Week 84
denoms
counts
group Id
OG000
value
91
units
Participants
description
The BCR-ABL ratio (%) represents the level of BCR-ABL fusion gene transcripts relative to a control gene (ABL) measured in peripheral blood samples using quantitative reverse transcription polymerase chain reaction (RT-PCR). Results are expressed as a percentage on the International Scale (IS), a standardized reporting method that allows comparison across laboratories. The BCR-ABL ratio is used to assess the molecular response to treatment, with lower values indicating a reduced disease burden.
dispersion Type
Standard Deviation
groups
description
Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.
id
OG000
title
NTRI Phase
param Type
MEAN
population Description
The nilotinib treatment re-initiation (NTRI) safety set included all participants who received at least one dose of study medication during the nilotinib treatment re-initiation phase.
reporting Status
POSTED
time Frame
Baseline; every 4 weeks up to Week 24; and every 12 weeks thereafter, up to Week 528
title
BCR-ABL Ratio (%) Over Time in Nilotinib Treatment Re-initiation Phase (NTRI)
Triangle