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NCT01784068 · OUTCOME

Number of Participants in Molecular Response 4.5 (MR4.5) at Multiple Time Points After Start of the Treatment-Free Remission (TFR) Phase

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Weeks 48, 96, 144, 192, and 264, and End of Years 6, 7, 8, 9, and 10

What was measured

This outcome measure was the number of participants in molecular response 4.5 (MR4.5) assessed at multiple timepoints after initiation of the treatment-free remission (TFR) phase of nilotinib. At each assessment time point, participants with available MR4.5 data were counted. Participants who reinitiated nilotinib treatment for less than 12 weeks prior to the respective assessment time point were excluded from the analysis at that time point. MR4.5 corresponds to a BCR-ABL transcript level ≤0.0032% on the International Scale (IS).

Analysis population: The full analysis set (FAS) included all participants who completed 52 weeks of nilotinib treatment in the NTCS phase and subsequently entered the TFR phase

Groups in this outcome

TFR Phase

Participants who completed the nilotinib treatment consolidation (NTCS) phase and maintained major molecular response entered the treatment-free remission (TFR) phase. During the TFR phase, nilotinib treatment was discontinued and participants were monitored regularly for molecular response.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
TFR Phase190

Reported measurements

Week 48 response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase90Not reportedNot reportedNot reportedNot reported
Week 96 response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase88Not reportedNot reportedNot reportedNot reported
Week 144 response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase87Not reportedNot reportedNot reportedNot reported
Week 192 response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase82Not reportedNot reportedNot reportedNot reported
Week 264 response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase76Not reportedNot reportedNot reportedNot reported
Week 312 (Year 6) response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase72Not reportedNot reportedNot reportedNot reported
Week 360 (Year 7) response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase69Not reportedNot reportedNot reportedNot reported
Week 408 (year 8) response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase67Not reportedNot reportedNot reportedNot reported
Week 468 (year 9) response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase64Not reportedNot reportedNot reportedNot reported
Week 528 (year 10) response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase48Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        90
    title
    Week 48 response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        88
    title
    Week 96 response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        87
    title
    Week 144 response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        82
    title
    Week 192 response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        76
    title
    Week 264 response
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        72
    title
    Week 312 (Year 6) response
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        69
    title
    Week 360 (Year 7) response
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        67
    title
    Week 408 (year 8) response
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        64
    title
    Week 468 (year 9) response
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        48
    title
    Week 528 (year 10) response
denoms
  1. counts
    1. group Id
      OG000
      value
      190
    units
    Participants
description
This outcome measure was the number of participants in molecular response 4.5 (MR4.5) assessed at multiple timepoints after initiation of the treatment-free remission (TFR) phase of nilotinib. At each assessment time point, participants with available MR4.5 data were counted. Participants who reinitiated nilotinib treatment for less than 12 weeks prior to the respective assessment time point were excluded from the analysis at that time point. MR4.5 corresponds to a BCR-ABL transcript level ≤0.0032% on the International Scale (IS).
groups
  1. description
    Participants who completed the nilotinib treatment consolidation (NTCS) phase and maintained major molecular response entered the treatment-free remission (TFR) phase. During the TFR phase, nilotinib treatment was discontinued and participants were monitored regularly for molecular response.
    id
    OG000
    title
    TFR Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
The full analysis set (FAS) included all participants who completed 52 weeks of nilotinib treatment in the NTCS phase and subsequently entered the TFR phase
reporting Status
POSTED
time Frame
Weeks 48, 96, 144, 192, and 264, and End of Years 6, 7, 8, 9, and 10
title
Number of Participants in Molecular Response 4.5 (MR4.5) at Multiple Time Points After Start of the Treatment-Free Remission (TFR) Phase
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice