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This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ponatinib | Drug | Iclusig 45mg, 15mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR | until 14 days after last administration |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects who satisfy CHR | at 3 months and 6 months from administration | |
| The percentage of subjects who satisfy CHR | at 3 months and 6 months from administration | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are prescribed Iclusig® tablets and provide written informed consent will be enrolled. The number of patients to be enrolled by each investigator will vary.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gaspel Hospital | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42174310 | Derived | Lee S, Kim HJ, Cheong JW, Shin HJ, Kong JH, Sohn SK, Yoon SS, Zang DY, Jung CW, Kim JA, Lee SE, Lee WS, Choi Y, Kim I, Han JJ, Kim MK, Chong SY, Kim DJ, Jo DY, Kim H, Kwak JY, Lee JH, Uhm J, Lee S, Lee MY, Kim DW. Real-world outcomes of ponatinib in heavily pretreated patients with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Ann Hematol. 2026 May 22. doi: 10.1007/s00277-026-07053-6. Online ahead of print. |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545373 | ponatinib |
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| The number of subjects who satisfy MCyR |
| at 3 months and 6 months from administration |
| The percentage of subjects who satisfy MCyR | at 3 months and 6 months from administration |
| The number of subjects who satisfy MMR | at 3 months and 6 months from administration |
| The percentage of subjects who satisfy MMR | at 3 months and 6 months from administration |
| 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 |