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NCT00109707 · OUTCOME

Number of Participants With Adverse Events and Serious Adverse Events to Evaluate Long Term Safety

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies · Source last updated 2021-06-29

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 Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)

What was measured

Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

Analysis population: Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.

Groups in this outcome

CML-CP With Prior Imatinib Only

Adult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

CML-AP With Prior Imatinib Only

Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

CML-CP

Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

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

Analysis denominator · Participants

GroupSource count
CML-CP With Prior Imatinib Only321
CML-AP With Prior Imatinib Only137
CML-CP49

Reported measurements

Serious Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CML-CP With Prior Imatinib Only61Not reportedNot reportedNot reportedNot reported
CML-AP With Prior Imatinib Only26Not reportedNot reportedNot reportedNot reported
CML-CP5Not reportedNot reportedNot reportedNot reported
Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CML-CP With Prior Imatinib Only57Not reportedNot reportedNot reportedNot reported
CML-AP With Prior Imatinib Only17Not reportedNot reportedNot reportedNot reported
CML-CP7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        5
    title
    Serious Adverse Events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        7
    title
    Adverse Events
denoms
  1. counts
    1. group Id
      OG000
      value
      321
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      49
    units
    Participants
description
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
groups
  1. description
    Adult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    OG000
    title
    CML-CP With Prior Imatinib Only
  2. description
    Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    OG001
    title
    CML-AP With Prior Imatinib Only
  3. description
    Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    OG002
    title
    CML-CP
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.
reporting Status
POSTED
time Frame
From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)
title
Number of Participants With Adverse Events and Serious Adverse Events to Evaluate Long Term Safety
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice