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NCT00113321 · OUTCOME

Overall Response

Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure · Source last updated 2012-08-07

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
Blood tests baseline and after completing 8-12 weeks of therapy

What was measured

Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.

Analysis population: Treated population (16 patients); No further analysis done since study terminated early due to low accrual.

Groups in this outcome

Decitabine

20 mg/m2 by vein (IV) over 1 hour daily x 5 days.

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

Analysis denominator · Participants

GroupSource count
Decitabine16

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Decitabine3Not reportedNot reportedNot reportedNot reported
No Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Decitabine13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    No Complete Response
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.
groups
  1. description
    20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
    id
    OG000
    title
    Decitabine
param Type
NUMBER
population Description
Treated population (16 patients); No further analysis done since study terminated early due to low accrual.
reporting Status
POSTED
time Frame
Blood tests baseline and after completing 8-12 weeks of therapy
title
Overall Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice