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NCT01784068 · OUTCOME

Progression-Free Survival (PFS) 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
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
From start of the treatment-free remission (TFR) phase up to Week 528

What was measured

Progression-free survival (PFS) was defined as the time from the start of the treatment-free remission (TFR) phase to the earliest occurrence of disease progression to accelerated phase (AP) or blast crisis (BC), or death due to any cause. Participants without an event on or before the data cut-off date were censored at the date of their last available disease assessment (cytogenetic, hematologic, or extramedullary assessment) or last contact for participants in follow-up.

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 treatment-free remission (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

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TFR PhaseNANot reportedNANAinsufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      190
    units
    Participants
description
Progression-free survival (PFS) was defined as the time from the start of the treatment-free remission (TFR) phase to the earliest occurrence of disease progression to accelerated phase (AP) or blast crisis (BC), or death due to any cause. Participants without an event on or before the data cut-off date were censored at the date of their last available disease assessment (cytogenetic, hematologic, or extramedullary assessment) or last contact for participants in follow-up.
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
MEDIAN
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 treatment-free remission (TFR) phase.
reporting Status
POSTED
time Frame
From start of the treatment-free remission (TFR) phase up to Week 528
title
Progression-Free Survival (PFS) After Start of the Treatment-Free Remission (TFR) Phase
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice