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NCT01165996 · OUTCOME

Proportion of Patients With Bone Marrow Evidence of Cytotoxicity.

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
6 weeks after treatment

What was measured

Cytotoxicity is the ability to destroy cells. This will be measured by taking bone marrow samples and measuring the damage to cells. The level of cell destruction will be correlated with clinical response criteria.

Analysis population: Patients with chromosomal abnormalities which were evaluable for follow-up 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. flow cytometry: Correlative studies DNA methylation analysis: Correlative studies cytogenetic analysis: Correlative studies decitabine: Given subcutaneously microarray analysis: Correlative studies gene expression analysis: Correlative studies pharmacological study: Correlative studies polymorphism analysis: Correlative studies

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
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
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Cytotoxicity is the ability to destroy cells. This will be measured by taking bone marrow samples and measuring the damage to cells. The level of cell destruction will be correlated with clinical response criteria.
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. flow cytometry: Correlative studies DNA methylation analysis: Correlative studies cytogenetic analysis: Correlative studies decitabine: Given subcutaneously microarray analysis: Correlative studies gene expression analysis: Correlative studies pharmacological study: Correlative studies polymorphism analysis: Correlative studies
    id
    OG000
    title
    Arm I: Decitabine 0.2mg/kg
param Type
NUMBER
population Description
Patients with chromosomal abnormalities which were evaluable for follow-up karyotyping
reporting Status
POSTED
time Frame
6 weeks after treatment
title
Proportion of Patients With Bone Marrow Evidence of Cytotoxicity.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice