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NCT01165996 · OUTCOME

Cytogenetic Response as Per IWG Criteria

Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome · Source last updated 2019-03-04

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
at 12 months

What was measured

Described as the number of patients with a major cytogenetic response (refers to disappearance of a cytogenetic abnormality) or a minor cytogenetic response (50% or more reduction of abnormal metaphases).

Analysis population: Patients that had cytogenetic abnormalities at baseline and were evaluable with follow-up metaphase karyotyping.

Groups in this outcome

Arm I: Decitabine 0.2mg/kg

INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts \< 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm I: Decitabine 0.2mg/kg11

Reported measurements

complete cytogenetic remission
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I: Decitabine 0.2mg/kg5Not reportedNot reportedNot reportedNot reported
partial cytogenetic remission
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I: Decitabine 0.2mg/kg2Not reportedNot reportedNot reportedNot reported
no cytogenetic remission
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I: Decitabine 0.2mg/kg4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    complete cytogenetic remission
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    partial cytogenetic remission
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    no cytogenetic remission
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Described as the number of patients with a major cytogenetic response (refers to disappearance of a cytogenetic abnormality) or a minor cytogenetic response (50% or more reduction of abnormal metaphases).
groups
  1. description
    INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts \< 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I: Decitabine 0.2mg/kg
param Type
NUMBER
population Description
Patients that had cytogenetic abnormalities at baseline and were evaluable with follow-up metaphase karyotyping.
reporting Status
POSTED
time Frame
at 12 months
title
Cytogenetic Response as Per IWG Criteria
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice