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NCT01165996 · OUTCOME

Proportion of Patients With Pharmacodynamic Evidence of Drug Effect.

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

Evidence of pharmacodynamic effect will be correlated with clinical response criteria. The pharmacodynamic effect of treatment is defined as the number of participants that had depletion DNMT1 with minimal DNA damage and cytotoxicity.

Analysis population: All subjects that had treatment with DNMT1 depletion.

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/kg25

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I: Decitabine 0.2mg/kg25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Evidence of pharmacodynamic effect will be correlated with clinical response criteria. The pharmacodynamic effect of treatment is defined as the number of participants that had depletion DNMT1 with minimal DNA damage and cytotoxicity.
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
All subjects that had treatment with DNMT1 depletion.
reporting Status
POSTED
time Frame
6 weeks after treatment
title
Proportion of Patients With Pharmacodynamic Evidence of Drug Effect.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice