NCT00071799 · OUTCOME

Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care · Source last updated 2019-10-29

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: Day 1 to 42 months

What was measured

Investigator determined responses followed IWG criteria for * complete remission(CR): repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia * partial remission(PR) is the same as CR for peripheral blood: bone marrow shows blasts decrease by \>=50% or a less advanced FAB classification from pretreatment * stable disease(SD) is a failure to achieve at least a partial remission, but with no evidence of progression for at least 2 months.

Analysis population: Intent to treat population.

Groups in this outcome

Azacitidine

Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.

Conventional Care

Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)

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
Azacitidine	179
Conventional Care	179

Reported measurements

Overall (Complete + Partial Remission)

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine	51	Not reported	Not reported	Not reported	Not reported
Conventional Care	21	Not reported	Not reported	Not reported	Not reported

Complete Remission

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine	30	Not reported	Not reported	Not reported	Not reported
Conventional Care	14	Not reported	Not reported	Not reported	Not reported

Partial Remission

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine	21	Not reported	Not reported	Not reported	Not reported
Conventional Care	7	Not reported	Not reported	Not reported	Not reported

Stable Disease

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine	75	Not reported	Not reported	Not reported	Not reported
Conventional Care	65	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 Pct Value
95
group Description
Overall (Complete + Partial Remission)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0001
statistical Method
Fisher Exact
ci Pct Value
95
group Description
Complete remission
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0150
statistical Method
Fisher Exact
ci Pct Value
95
group Description
Partial Remission
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0094
statistical Method
Fisher Exact
ci Pct Value
95
group Description
Stable Disease
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.3297
statistical Method
Fisher Exact

Complete source fields

analyses

ci Pct Value
95
group Description
Overall (Complete + Partial Remission)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0001
statistical Method
Fisher Exact
ci Pct Value
95
group Description
Complete remission
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0150
statistical Method
Fisher Exact
ci Pct Value
95
group Description
Partial Remission
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0094
statistical Method
Fisher Exact
ci Pct Value
95
group Description
Stable Disease
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.3297
statistical Method
Fisher Exact

classes

categories
measurements
group Id
OG000
value
51
group Id
OG001
value
21
title
Overall (Complete + Partial Remission)
categories
measurements
group Id
OG000
value
30
group Id
OG001
value
14
title
Complete Remission
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
7
title
Partial Remission
categories
measurements
group Id
OG000
value
75
group Id
OG001
value
65
title
Stable Disease

denoms

counts
group Id
OG000
value
179
group Id
OG001
value
179
units
Participants

description

groups

description
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
id
OG000
title
Azacitidine
description
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
id
OG001
title
Conventional Care

param Type

NUMBER

population Description

Intent to treat population.

reporting Status

POSTED

time Frame

Day 1 to 42 months

title

Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)

type

SECONDARY

unit Of Measure

participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice