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NCT01698905 · OUTCOME

Proportion of Participants With Stable MR4.5 in Nilotinib Re-initiation Phase

Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) · Source last updated 2026-08-12

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
at 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks, 288 weeks, 336 weeks, 384 weeks and 432 weeks

What was measured

Percentage of participants who were in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at multiple time points after achievement of that response in the nilotinib re-initiation phase for those timepoints.

Analysis population: Nilotinib treatment re-initiation (NTRI) Safety set included participants who achieved MR4.5 at least once in nilotinib re-initiation phase

Groups in this outcome

NTRI Phase

If a patient had a confirmed loss of MR4 (two consecutive BCR-ABL1 \>0.01% IS) or loss of MMR (BCR-ABL1 \>0.1% IS) in the TFR phase, the patient restarted nilotinib treatment.

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

Analysis denominator · Participants

GroupSource count
NTRI Phase57

Reported measurements

Stable MR4.5 for 48 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase46Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 96 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase43Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 144 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase39Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 192 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase35Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 240 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase29Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 288 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase25Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 336 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase23Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 384 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase21Not reportedNot reportedNot reportedNot reported
Stable MR4.5 for 432 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        46
    title
    Stable MR4.5 for 48 weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        43
    title
    Stable MR4.5 for 96 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        39
    title
    Stable MR4.5 for 144 weeks
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    Stable MR4.5 for 192 weeks
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Stable MR4.5 for 240 weeks
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Stable MR4.5 for 288 weeks
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Stable MR4.5 for 336 weeks
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Stable MR4.5 for 384 weeks
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Stable MR4.5 for 432 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    units
    Participants
description
Percentage of participants who were in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at multiple time points after achievement of that response in the nilotinib re-initiation phase for those timepoints.
groups
  1. description
    If a patient had a confirmed loss of MR4 (two consecutive BCR-ABL1 \>0.01% IS) or loss of MMR (BCR-ABL1 \>0.1% IS) in the TFR phase, the patient restarted nilotinib treatment.
    id
    OG000
    title
    NTRI Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
Nilotinib treatment re-initiation (NTRI) Safety set included participants who achieved MR4.5 at least once in nilotinib re-initiation phase
reporting Status
POSTED
time Frame
at 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks, 288 weeks, 336 weeks, 384 weeks and 432 weeks
title
Proportion of Participants With Stable MR4.5 in Nilotinib Re-initiation Phase
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice