NCT00071799 · STUDY IN CONTEXT

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.

Intent to treat population. Includes participants who died and participants who were censored.

→

primary · POSTED

Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact. Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification.

Intent to treat population. Includes participants who died and those who were censored.

→

secondary · POSTED

The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.

Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.

→

secondary · POSTED

The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.

Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.

→

secondary · POSTED

Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.

Intent to treat population

→

secondary · POSTED

Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.

Intent to treat population

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-myelodysplastic-syndromes
nct id: NCT00071799
trial label: A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0000
source section id
NCT00071799-om-0000
source outcome index
0
endpoint
Kaplan-Meier Estimates for Median Time to Death From Any Cause
endpoint definition
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.
time origin
Day 1 (randomization) to 42 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population. Includes participants who died and participants who were censored.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0001
source section id
NCT00071799-om-0001
source outcome index
1
endpoint
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause
endpoint definition
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact. Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification.
time origin
Day 1 (randomization) to 42 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population. Includes participants who died and those who were censored.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0002
source section id
NCT00071799-om-0002
source outcome index
2
endpoint
Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First
endpoint definition
The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.
time origin
Day 1 (randomization) to 42 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0003
source section id
NCT00071799-om-0003
source outcome index
3
endpoint
Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)
endpoint definition
The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.
time origin
Day 1 (randomization) to 42 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0004
source section id
NCT00071799-om-0004
source outcome index
4
endpoint
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
endpoint definition
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
time origin
Day 1 (randomization) to 42 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0005
source section id
NCT00071799-om-0005
source outcome index
5
endpoint
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline
endpoint definition
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
time origin
Day 1 (randomization) to 42 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0000
arm key
OG000
arm label
Azacitidine
regimen
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0000
arm key
OG001
arm label
Conventional Care
regimen
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0001
arm key
OG000
arm label
Azacitidine
regimen
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0001
arm key
OG001
arm label
Conventional Care
regimen
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0002
arm key
OG000
arm label
Azacitidine
regimen
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0002
arm key
OG001
arm label
Conventional Care
regimen
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0003
arm key
OG000
arm label
Azacitidine
regimen
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0003
arm key
OG001
arm label
Conventional Care
regimen
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0004
arm key
OG000
arm label
Azacitidine
regimen
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
analyzed count
111
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0004
arm key
OG001
arm label
Conventional Care
regimen
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
analyzed count
114
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0005
arm key
OG000
arm label
Azacitidine
regimen
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
analyzed count
68
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
outcome key
om-0005
arm key
OG001
arm label
Conventional Care
regimen
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00071799-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
harm key
EG000
source section id
NCT00071799-ae
event group key
EG000
event group label
Azacitidine
serious affected
114
serious at risk
175
other affected
175
other at risk
175
frequency threshold
5
collection period
Treatment-emergent AEs for the 'core study' from Day 1 to 42 months.
event definition
Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
harm key
EG001
source section id
NCT00071799-ae
event group key
EG001
event group label
Best Supportive Care Only
serious affected
71
serious at risk
102
other affected
86
other at risk
102
frequency threshold
5
collection period
Treatment-emergent AEs for the 'core study' from Day 1 to 42 months.
event definition
Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
harm key
EG002
source section id
NCT00071799-ae
event group key
EG002
event group label
Low-dose Cytarabine
serious affected
27
serious at risk
44
other affected
44
other at risk
44
frequency threshold
5
collection period
Treatment-emergent AEs for the 'core study' from Day 1 to 42 months.
event definition
Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00071799
harm key
EG003
source section id
NCT00071799-ae
event group key
EG003
event group label
Standard Chemotherapy
serious affected
14
serious at risk
19
other affected
19
other at risk
19
frequency threshold
5
collection period
Treatment-emergent AEs for the 'core study' from Day 1 to 42 months.
event definition
Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice