Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01784068 · OUTCOME

Percentage of Participants With Treatment-emergent Adverse Events During the Entire Study

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
From first dose of nilotinib through up to approximately 11 years of study participation, including the NTCS, TFR, and NTRI phases

What was measured

This outcome measure summarized the overall occurrence of adverse events related to nilotinib during the study. A study drug-related adverse event was defined as any adverse event assessed by the investigator as related to nilotinib and reported during the nilotinib treatment consolidation (NTCS) phase, the treatment-free remission (TFR) phase, or the nilotinib treatment re-initiation (NTRI) phase.

Analysis population: The safety population included all participants who received at least one dose of nilotinib during any study phase (NTCS or NTRI).

Groups in this outcome

NTCS Phase

Participants who had received at least 2 years of first-line nilotinib treatment and achieved a deep molecular response (MR4.5) entered the nilotinib treatment consolidation (NTCS) phase. During this phase, participants received nilotinib 300 mg twice daily for 52 weeks.

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.

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

GroupSource count
NTCS Phase215
TFR Phase190
NTRI Phase91

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTCS Phase83Not reportedNot reportedNot reportedNot reported
TFR Phase40Not reportedNot reportedNot reportedNot reported
NTRI Phase70Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        70
denoms
  1. counts
    1. group Id
      OG000
      value
      215
    2. group Id
      OG001
      value
      190
    3. group Id
      OG002
      value
      91
    units
    Participants
description
This outcome measure summarized the overall occurrence of adverse events related to nilotinib during the study. A study drug-related adverse event was defined as any adverse event assessed by the investigator as related to nilotinib and reported during the nilotinib treatment consolidation (NTCS) phase, the treatment-free remission (TFR) phase, or the nilotinib treatment re-initiation (NTRI) phase.
groups
  1. description
    Participants who had received at least 2 years of first-line nilotinib treatment and achieved a deep molecular response (MR4.5) entered the nilotinib treatment consolidation (NTCS) phase. During this phase, participants received nilotinib 300 mg twice daily for 52 weeks.
    id
    OG000
    title
    NTCS Phase
  2. 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
    OG001
    title
    TFR Phase
  3. 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
    OG002
    title
    NTRI Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population included all participants who received at least one dose of nilotinib during any study phase (NTCS or NTRI).
reporting Status
POSTED
time Frame
From first dose of nilotinib through up to approximately 11 years of study participation, including the NTCS, TFR, and NTRI phases
title
Percentage of Participants With Treatment-emergent Adverse Events During the Entire Study
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice