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The aim of this study was to investigate the safety, tolerability, and effectiveness of eltrombopag in combination with immunosuppressive therapy (IST) in real world practice in pediatric patients with severe aplastic anemia (sAA) in Korea. The study used data over a 6-month period extracted from patients' medical charts (electronic medical records) starting from the initiation of eltrombopag treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag and IST Treatment Cohort | Pediatric patients with sAA who received first-line eltrombopag in combination with IST. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence of all AEs/adverse drug reactions (ADRs), SAEs/serious adverse drug reactions (SADRs), and unexpected AEs/ADRs. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR includes complete response (CR) and partial response (PR). CR was defined as meeting all three of the following criteria:
PR was defined as hematologic improvement that did not meet the criteria for CR, but also did not meet the criteria for sAA. | 6 months |
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Inclusion criteria:
Exclusion criteria:
None.
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Pediatric patients with sAA who initiated eltrombopag and IST treatment in Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07963 | United States |
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| Label | URL |
|---|---|
| Link to study results | View source |
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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 |
| D001855 | Bone Marrow Diseases |
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