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To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation [up to 5 years] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.
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| Measure | Description | Time Frame |
|---|---|---|
| Hematological response at 2 years after the start of romiplostim treatment in Study 531-003/531-004 | 2 years | |
| Hematological response at up to 5 years after the start of romiplostim treatment in Study 531-003/531-004 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of hematological response, and the presence or absence of occurrence of new chromosomal abnormality or transformation to AML/MDS. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled in Study 531-003/531-004
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| Name | Affiliation | Role |
|---|---|---|
| Hirohito Yamazaki | Kanazawa University Hospital, Blood Transfusion Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology | Kanazawa | Ishikawa-ken | 920-0934 | Japan |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| 52, 78, 104, 130, 156, 182, 208, 234, 260 weeks |
| D001855 | Bone Marrow Diseases |