Chronic Myeloid Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Conditions
Brief summary
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.
Interventions
DRUGPonatinib
Iclusig 45mg, 15mg
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment
Exclusion criteria
* Patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug * Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects who satisfy CHR | at 3 months and 6 months from administration |
| The number of subjects who satisfy MCyR | at 3 months and 6 months from administration |
| The number of subjects who satisfy CHR | 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 |
| The percentage of subjects who satisfy MCyR | at 3 months and 6 months from administration |
Countries
South Korea
Outcome results
None listed