NCT00708721 · OUTCOME

Number of Participants Who Experienced a Dose-Limiting Toxicity

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 who experienced a DLT
Interval / dispersion: Not reported
Time frame: 28 days after the first admistration of oral clofarabine

What was measured

Dose-limiting toxicity was defined as any nonhematologic toxicity grade 3 or greater except for alopecia or nausea (which may be of grade 4 severity), or any grade 4 hematologic toxicity lasting more than 28 days after the last day of therapy.

Analysis population: 9 out of 11 participants were evaluable for this outcome.

Groups in this outcome

Cohort 1: 10 mg/Day for 10 Days

Not reported

Cohort 2: 1 mg/Day for 10 Days

Not reported

Cohort 3: 1 mg/Day for 7 Days

Not reported

Not Evaluable

Not reported

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

Analysis denominator · Participants

Group	Source count
Cohort 1: 10 mg/Day for 10 Days	2
Cohort 2: 1 mg/Day for 10 Days	4
Cohort 3: 1 mg/Day for 7 Days	3
Not Evaluable	2

Reported measurements

Source class 1

Values in participants who experienced a DLT · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: 10 mg/Day for 10 Days	2	Not reported	Not reported	Not reported	Not reported
Cohort 2: 1 mg/Day for 10 Days	4	Not reported	Not reported	Not reported	Not reported
Cohort 3: 1 mg/Day for 7 Days	0	Not reported	Not reported	Not reported	Not reported
Not Evaluable	0	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Num Sides
TWO_SIDED
estimate Comment
Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.
group Ids
OG000
OG001
non Inferiority Type
OTHER
param Type
Maximum Tolerated Dose
param Value
1

Complete source fields

analyses

ci Num Sides
TWO_SIDED
estimate Comment
Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.
group Ids
OG000
OG001
non Inferiority Type
OTHER
param Type
Maximum Tolerated Dose
param Value
1

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
0

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
2
units
Participants

description

groups

id
OG000
title
Cohort 1: 10 mg/Day for 10 Days
id
OG001
title
Cohort 2: 1 mg/Day for 10 Days
id
OG002
title
Cohort 3: 1 mg/Day for 7 Days
id
OG003
title
Not Evaluable

param Type

NUMBER

population Description

9 out of 11 participants were evaluable for this outcome.

reporting Status

POSTED

time Frame

28 days after the first admistration of oral clofarabine

title

Number of Participants Who Experienced a Dose-Limiting Toxicity

type

PRIMARY

unit Of Measure

participants who experienced a DLT

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

Preserved source evidence · Not medical advice