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NCT00708721 · OUTCOME

Number of Participants With Adverse Events

Low-dose Oral Clofarabine for the Treatment of IPSS INT-1, INT-2 or HIGH Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia · Source last updated 2017-06-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants experiencing adverse events
Interval / dispersion
Not reported
Time frame
To 30 days after end of treatment or until full resolution.

What was measured

NCI CTCAE version 3.0 will be used to assess adverse events. The number of participants experiencing adverse events and the number of adverse events per patient will be documented through the course of study.

Analysis population: All participants experienced at least 1 adverse event (100% of the patient population; 11/11 participants)

Groups in this outcome

All Patients

All participants enrolled.

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

Analysis denominator · Participants

GroupSource count
All Patients11

Reported measurements

Source class 1
Values in participants experiencing adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
NCI CTCAE version 3.0 will be used to assess adverse events. The number of participants experiencing adverse events and the number of adverse events per patient will be documented through the course of study.
groups
  1. description
    All participants enrolled.
    id
    OG000
    title
    All Patients
param Type
NUMBER
population Description
All participants experienced at least 1 adverse event (100% of the patient population; 11/11 participants)
reporting Status
POSTED
time Frame
To 30 days after end of treatment or until full resolution.
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
participants experiencing adverse events

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

Preserved source evidence · Not medical advice