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Observational medical record review of newly diagnosed CML-CP participants in China
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants newly diagnosed with CML-CP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants receiving each first-line treatment option | 2 years | |
| Number of participants with complete cytogenetic response | Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM) | 2 years |
| Number of participants with major molecular response (MMR) | Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA | 2 years |
| Number of participants of each initial dose schema | 2 years | |
| Starting dose of each first-line agent | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of demographic characteristics | Including age, sex, height, weight | 2 years |
| Distribution of clinical characteristics | Including health insurance and comorbid conditions |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Multi-center, observational, medical record review of approximately 1000 newly diagnosed CML-CP patients in China
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Tianjin | Tianjin Municipality | 300020 | China |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| 2 years |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D010677 | Philadelphia Chromosome |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014178 | Translocation, Genetic |
| D002869 | Chromosome Aberrations |
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