Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
738 patients screened from 98 investigator sites. Randomized patients contributed by 79 investigator sites.

Reporting Groups

	Description
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)

Participant Flow:   Overall Study

	Azacitidine	Conventional Care
STARTED	179	179 [1]
COMPLETED	109 [2]	81 [3]
NOT COMPLETED	70	98
Adverse Event	19	10
Protocol Violation	1	7
Lost to Follow-up	1	1
Withdrawal by Subject	15	37
Physician Decision	0	2
Lack of Efficacy	11	18
Disease Progression	23	20
Different Central+Local Pathology Review	0	1
Not Documented	0	2

Reporting Groups

	Description
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)

Baseline Measures

	Azacitidine	Conventional Care	Total
Number of Participants   [units: participants]	179	179	358
Age   [units: years] Mean ± Standard Deviation	68.0  ± 7.57	69.2  ± 7.87	68.6  ± 7.73
Gender   [units: participants]
Female	47	60	107
Male	132	119	251
Race/Ethnicity, Customized   [units: participants]
Caucasian	177	175	352
Black or African American	0	0	0
Asian/Oriental	2	3	5
Hispanic	0	1	1
Other	0	0	0
French-American-British (FAB) Classification [1] [units: participants]
Refractory anemia with excess blasts (RAEB)	104	103	207
RAEB in transformation	61	62	123
Modified chronic myelomonocytic leukemia	6	5	11
Acute myeloid leukemia	1	1	2
Myeloproliferative disease	4	2	6
Indeterminate	3	6	9
International Prognostic Scoring System (IPSS) [2] [units: participants]
Intermediate risk level 1 (0.5-1.0)	5	13	18
Intermediate risk level 2 (1.5-2.0)	76	70	146
High risk (2.5-3.5)	82	85	167
Not applicable	5	3	8
Indeterminate	11	8	19
World Health Organization (WHO) Classification [3] [units: participants]
Refractory anemia with excess blasts - 1	14	17	31
Refractory anemia with excess blasts - 2	98	95	193
Chronic myelomonocytic leukemia - 1 (CMMoL-1)	1	0	1
Chronic myelomonocytic leukemia - 2 (CMMoL-2)	10	5	15
Acute myeloid leukemia	55	58	113
Indeterminate	1	4	5
Body Surface Area   [units: meters squared] Mean ± Standard Deviation	1.9  ± 0.19	1.8  ± 0.19	1.9  ± 0.19
Weight   [units: kilograms] Mean ± Standard Deviation	76.5  ± 14.08	74.6  ± 13.58	75.6  ± 13.85

1.  Primary:

Kaplan-Meier Estimates for Median Time to Death From Any Cause   [ Time Frame: Day 1 (randomization) to 42 months ]

2.  Primary:

Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause   [ Time Frame: Day 1 (randomization) to 42 months ]

3.  Primary:

Number of Participants Who Died   [ Time Frame: 42 months ]

4.  Secondary:

Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First   [ Time Frame: Day 1 (randomization) to 42 months ]

5.  Secondary:

Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)   [ Time Frame: Day 1 (randomization) to 42 months ]

6.  Secondary:

Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline   [ Time Frame: Day 1 (randomization) to 42 months ]

7.  Secondary:

Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline   [ Time Frame: Day 1 (randomization) to 42 months ]

8.  Secondary:

Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline   [ Time Frame: Day 1 (randomization) to 42 months ]

9.  Secondary:

Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline   [ Time Frame: Day 1 (randomization) to 42 months ]

10.  Secondary:

Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)   [ Time Frame: Day 1 to 42 months ]

11.  Secondary:

Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee   [ Time Frame: Day 1 to 42 months ]

12.  Secondary:

Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause   [ Time Frame: Day 1 (randomization) to 42 months ]

13.  Secondary:

Duration of Any Hematologic Improvement   [ Time Frame: Day 1 (randomization) to 42 months ]

14.  Secondary:

Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals   [ Time Frame: Day 1 (randomization) to 42 months ]

15.  Secondary:

Number of Participants in Different Categories of Adverse Experiences During Core Study Period   [ Time Frame: Day 1 (randomization) to 42 months ]

16.  Post-Hoc:

Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML) Based on the Last Bone Marrow Assessment   [ Time Frame: Day 1 (randomization) to 42 months ]