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The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.
This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospectively enrolled cohort | Participants who initiate Azacitidine (AZA) before enrollment | ||
| Prospectively enrolled cohort | Participants who initiate AZA initiation at enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 12 Months | |
| Incidence of Serious Adverse Events (SAEs) | Up to 12 Months | |
| Incidence of Adverse Drug Reactions (ADRs) | Up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease | Up to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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The study population will consist of participants enrolled retrospectively, who initiate azacitidine (AZA) before enrollment and participants enrolled prospectively, who initiate AZA initiation at enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Tianjin | Tianjin Municipality | 300010 | China |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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