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NCT01784068 · OUTCOME

Percentage of Participants in MR4.5 (BCR-ABL ≤ 0.0032% IS) at 48 Weeks After Start of 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
48 weeks in TFR

What was measured

The outcome measure was the percentage of participants in molecular response 4.5 (MR4.5) at 48 weeks after initiation of the treatment-free remission (TFR) phase. Participants who required reinitiation of treatment were considered non-responders. MR4.5 corresponds to a BCR-ABL transcript level ≤0.0032% on the International Scale (IS), representing a deep molecular response.

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 at the corresponding response category.

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TFR Phase47.4Not reported40.154.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.1
        upper Limit
        54.7
        value
        47.4
denoms
  1. counts
    1. group Id
      OG000
      value
      190
    units
    Participants
description
The outcome measure was the percentage of participants in molecular response 4.5 (MR4.5) at 48 weeks after initiation of the treatment-free remission (TFR) phase. Participants who required reinitiation of treatment were considered non-responders. MR4.5 corresponds to a BCR-ABL transcript level ≤0.0032% on the International Scale (IS), representing a deep molecular response.
dispersion Type
95% Confidence Interval
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
NUMBER
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 at the corresponding response category.
reporting Status
POSTED
time Frame
48 weeks in TFR
title
Percentage of Participants in MR4.5 (BCR-ABL ≤ 0.0032% IS) at 48 Weeks After Start of TFR Phase
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice