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NCT00109707 · OUTCOME

Participants With (MMR) Major Molecular Response (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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to End of the Treatment (Approximately 7.5 years)

What was measured

MMR was defined for participants who demonstrated a reduction in BCR-ABL/control gene % transcripts to ≤0.1% based on international scale. The control gene used may have been either BCR or ABL.

Analysis population: Full Analysis Set (FAS): All participants who received at least one dose of study medication. Major molecular response was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8)

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).

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 Only299
CML-AP With Prior Imatinib Only122

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CML-CP With Prior Imatinib Only106Not reportedNot reportedNot reportedNot reported
CML-AP With Prior Imatinib Only18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        18
denoms
  1. counts
    1. group Id
      OG000
      value
      299
    2. group Id
      OG001
      value
      122
    units
    Participants
description
MMR was defined for participants who demonstrated a reduction in BCR-ABL/control gene % transcripts to ≤0.1% based on international scale. The control gene used may have been either BCR or ABL.
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
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication. Major molecular response was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8)
reporting Status
POSTED
time Frame
Up to End of the Treatment (Approximately 7.5 years)
title
Participants With (MMR) Major Molecular Response (Phase II)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice