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The purpose of this study is to provide a contemporary view and offer invaluable insights into the demographic profiles, clinical characteristics, treatments, and real-world outcomes of individuals with myelodysplastic syndromes (MDS) in Asia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Participants diagnosed with myelodysplastic syndromes (MDS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescribed treatments for myelodysplastic syndromes (MDS) | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant age | Baseline | |
| Participant sex | Baseline | |
| Participant race | Baseline | |
| Participant weight | Baseline | |
| Participant height | Baseline | |
| Participant body mass index (BMI) | Baseline | |
| Participant smoking status | Baseline | |
| Participant drinking status | Baseline | |
| Family history of MDS or other hematopoietic cancers | Baseline | |
| Participant myelodysplastic syndromes diagnosis information | Baseline | |
| Participant Eastern Cooperative Oncology Group (ECOG) Performance status at diagnosis | Baseline | |
| Participant comorbidities at diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Initial treatment received following diagnosis | Baseline | |
| Prior treatments and concomitant medications received | Baseline | |
| Subsequent treatments received |
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Inclusion Criteria:
Retrospective enrolment of Myelodysplastic Syndrome (MDS) participants:
Inclusion criteria for the prospective enrolment of MDS participants:
Exclusion Criteria:
• None
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The registry will include adults who were/are newly diagnosed with myelodysplastic syndromes (MDS) in Asia (Singapore, South Korea and Taiwan).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0003 | Singapore | 169608 | Singapore |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Baseline |
| Participant Charlson comorbidity index (CCI) score at diagnosis | Baseline |
| Prior clinical diagnosis of other cancers | Baseline |
| Prior clinical diagnosis of hematological diseases | Baseline |
| Anemia status at diagnosis | Bseline |
| Thrombocytopenia status at diagnosis | Baseline |
| Neutropenia status at diagnosis | Baseline |
| Iron overload status at diagnosis | Baseline |
| Red blood cell (RBC) transfusion dependence status at diagnosis | Baseline |
| International Prognostic Scoring System (IPSS) score at diagnosis | Baseline |
| Revised International Prognostic Scoring System (IPSS-R) score at diagnosis | Baseline |
| Molecular International Prognostic Scoring System (IPSS-M) score at diagnosis | Baseline |
| Bone marrow aspirate results | Baseline and up to 2-years |
| Presence of dysplasia | Baseline and up to 2-years |
| Cytogenetic test results | Baseline and up to 2-years |
| Mutation test results at diagnosis | Baseline |
| Complete blood count test results at diagnosis | Baseline |
| Mean corpuscular volume (MCV) | Baseline and up to 2-years |
| C-reactive protein (CRP) | Baseline and up to 2-years |
| Serum ferritin (SF) level | Baseline and up to 2-years |
| Serum erythropoietin levels | Baseline and up to 2-years |
| Lactate dehydrogenase (LDH) | Baseline and up to 2-years |
| Up to 2-years |
| Time from diagnosis to treatment initiation | Baseline |
| Treatment duration | Up to 2-years |
| Real-world overall survival (rwOS) | Baseline and up to 2-years |
| Time to disease-risk progression (per IPSS-R) | Baseline and up to 2-years |
| Time to acute myeloid leukemia (AML) progression | Baseline and up to 2-years |
| Time to iron overload | Baseline and up to 2-years |
| Overall response rate (ORR) | Baseline and up to 2-years |
| Duration of response (DOR) | Baseline and up to 2-years |
| Real-world relapse-free survival (rwRFS) | Baseline and up to 2-years |
| Local Institution - 002 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
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| Local Institution - 0001 | Taipei | 100229 | Taiwan |
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