Trial · NCT00071799

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

NCT00071799, Phase 3, Completed, Celgene; results first posted 2010-07-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care. Trials, record NCT00071799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00071799

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care
NCT number: NCT00071799
Status: Completed
Phases: Phase 3
Enrollment: 358 participants, actual
Lead sponsor: Celgene
Conditions: Myelodysplastic Syndromes
Interventions: Azacitidine, Physician Choice
First posted: 2003-11-05
Last updated: 2019-10-29
Results first posted: 2010-07-05

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Kaplan-Meier Estimates for Median Time to Death From Any Cause	Day 1 (randomization) to 42 months	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.
Primary	Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Day 1 (randomization) to 42 months	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.
Primary	Number of Participants Who Died	42 months	Count of participants who died during the study
Secondary	Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First	Day 1 (randomization) to 42 months	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.
Secondary	Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)	Day 1 (randomization) to 42 months	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.
Secondary	Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline	Day 1 (randomization) to 42 months	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.
Secondary	Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline	Day 1 (randomization) to 42 months	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.
Secondary	Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline	Day 1 (randomization) to 42 months	Summary of dependence and independence from platelet 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.
Secondary	Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline	Day 1 (randomization) to 42 months	Summary of dependence and independence from platelet 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.
Secondary	Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)	Day 1 to 42 months	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.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Kaplan-Meier Estimates for Median Time to Death From Any Cause	Day 1 (randomization) to 42 months	Intent to treat population. Includes participants who died and participants who were censored.	months	NUMBER
PRIMARY	Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Day 1 (randomization) to 42 months	Intent to treat population. Includes participants who died and those who were censored.	months	NUMBER
SECONDARY	Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First	Day 1 (randomization) to 42 months	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.	months	MEDIAN
SECONDARY	Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)	Day 1 (randomization) to 42 months	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.	months	MEDIAN
SECONDARY	Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline	Day 1 (randomization) to 42 months	Intent to treat population	participants	NUMBER
SECONDARY	Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline	Day 1 (randomization) to 42 months	Intent to treat population	participants	NUMBER
SECONDARY	Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline	Day 1 (randomization) to 42 months	Intent to treat population	participants	NUMBER
SECONDARY	Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline	Day 1 (randomization) to 42 months	Intent to treat population	participants	NUMBER
SECONDARY	Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)	Day 1 to 42 months	Intent to treat population.	participants	NUMBER
SECONDARY	Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee	Day 1 to 42 months	Intent to treat population.	participants	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group106

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Kaplan-Meier Estimates for Median Time to Death From Any Cause	Azacitidine		24.46	months
Kaplan-Meier Estimates for Median Time to Death From Any Cause	Conventional Care		15.02	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Azacitidine	Age <65 years	11.31	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Conventional Care	Age <65 years	7.87	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Azacitidine	Age >= 65 years	24.46	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Conventional Care	Age >= 65 years	13.87	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Azacitidine	Age >= 75 years	8.92	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Conventional Care	Age >= 75 years	6.20	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Azacitidine	Gender: Male	24.46	months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause	Conventional Care	Gender: Male	15.02	months

1 to 10 of 106Source ClinicalTrials.gov

See all 106 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Azacitidine	179
Overall Study	STARTED	Conventional Care	179
Overall Study	COMPLETED	Azacitidine	109
Overall Study	COMPLETED	Conventional Care	81
Overall Study	NOT COMPLETED	Azacitidine	70
Overall Study	NOT COMPLETED	Conventional Care	98

Source ClinicalTrials.gov

Adverse events1,556

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Azacitidine	84	175
other	Anaemia	Blood and lymphatic system disorders	Best Supportive Care Only	42	102
other	Anaemia	Blood and lymphatic system disorders	Low-dose Cytarabine	19	44
other	Anaemia	Blood and lymphatic system disorders	Standard Chemotherapy	11	19
other	Coagulopathy	Blood and lymphatic system disorders	Azacitidine	0	175
other	Coagulopathy	Blood and lymphatic system disorders	Best Supportive Care Only	0	102
other	Coagulopathy	Blood and lymphatic system disorders	Low-dose Cytarabine	0	44
other	Coagulopathy	Blood and lymphatic system disorders	Standard Chemotherapy	2	19
other	Febrile neutropenia	Blood and lymphatic system disorders	Azacitidine	6	175
other	Febrile neutropenia	Blood and lymphatic system disorders	Best Supportive Care Only	8	102

1 to 10 of 1,556Source ClinicalTrials.gov

See all 1,556 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Azacitidine
Total, all-cause mortality	Best Supportive Care Only
Total, all-cause mortality	Low-dose Cytarabine
Total, all-cause mortality	Standard Chemotherapy
Total, other adverse events	Azacitidine	175	175
Total, other adverse events	Best Supportive Care Only	86	102
Total, other adverse events	Low-dose Cytarabine	44	44
Total, other adverse events	Standard Chemotherapy	19	19
Total, serious adverse events	Azacitidine	114	175
Total, serious adverse events	Best Supportive Care Only	71	102

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19230772	RESULT	PubMed
20026804	RESULT	PubMed
20136825	RESULT	PubMed
20394651	RESULT	PubMed
20451404	RESULT	PubMed
23585522	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Azacitidine vs Conventional Care: Number of Participants Who Died

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00071799

GET https://conductscience.org/api/trials/v1/NCT00071799/results?page=2

API reference For AI assistants