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NCT00109707 · OUTCOME

Number of Participants With Overall Major Cytogenetic Responses (Phase II)

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to End of the Treatment (Approximately 7.5 years)

What was measured

Cytogenetic responses (CyRs) in CML are based on the percentage of Ph+ metaphases in bone marrow; a value of 0% Ph+ metaphases defines a complete cytogenetic response (CCyR) and \>0% to 35% defines a major cytogenetic response (MCyR). Achievement of CCyR is associated with a significant survival advantage in participants with CML-CP. MCyR was categorized as either CCyR or partial cytogenetic response (PCyR).

Analysis population: Full Analysis Set (FAS): All participants who received at least one dose of study medication

Groups in this outcome

CML-CP With Prior Imatinib Only

Adult participants PH+ CML-CP 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 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

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CML-CP With Prior Imatinib Only191Not reportedNot reportedNot reportedNot reported
CML-AP With Prior Imatinib Only44Not reportedNot reportedNot reportedNot reported
CML-CP22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        191
      2. group Id
        OG001
        value
        44
      3. group Id
        OG002
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      321
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      49
    units
    Participants
description
Cytogenetic responses (CyRs) in CML are based on the percentage of Ph+ metaphases in bone marrow; a value of 0% Ph+ metaphases defines a complete cytogenetic response (CCyR) and \>0% to 35% defines a major cytogenetic response (MCyR). Achievement of CCyR is associated with a significant survival advantage in participants with CML-CP. MCyR was categorized as either CCyR or partial cytogenetic response (PCyR).
groups
  1. description
    Adult participants PH+ CML-CP 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 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
NUMBER
population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication
reporting Status
POSTED
time Frame
Up to End of the Treatment (Approximately 7.5 years)
title
Number of Participants With Overall Major Cytogenetic Responses (Phase II)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice