NCT00425477 · OUTCOME

Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements

Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia · Source last updated 2018-10-05

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

Measure: MEAN
Unit: neutrophils/mm^3
Interval / dispersion: Standard Error
Time frame: Baseline and after two cycles

What was measured

ANC count at baseline and after two cycles were measured and compared. Due to the limited number of clinical responders, the changes in transfusion requirements were not measured.

Groups in this outcome

Bexarotene + GM-CSF

BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.

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
Bexarotene + GM-CSF	13

Reported measurements

ANC at baseline

Values in neutrophils/mm^3 · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Bexarotene + GM-CSF	524	95	Not reported	Not reported	Not reported

ANC after 2 cycles

Values in neutrophils/mm^3 · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Bexarotene + GM-CSF	931	244	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
95
value
524
title
ANC at baseline
categories
measurements
group Id
OG000
spread
244
value
931
title
ANC after 2 cycles

denoms

counts
group Id
OG000
value
13
units
Participants

description

ANC count at baseline and after two cycles were measured and compared. Due to the limited number of clinical responders, the changes in transfusion requirements were not measured.

dispersion Type

Standard Error

groups

description
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
id
OG000
title
Bexarotene + GM-CSF

param Type

MEAN

reporting Status

POSTED

time Frame

Baseline and after two cycles

title

Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements

type

SECONDARY

unit Of Measure

neutrophils/mm^3

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

Preserved source evidence · Not medical advice