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.
Study Type
OBSERVATIONAL
Enrollment
50
Iclusig 45mg, 15mg
Kosin University Gaspel Hospital
Busan, South Korea
The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Time frame: until 14 days after last administration
The number of subjects who satisfy CHR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy CHR
Time frame: at 3 months and 6 months from administration
The number of subjects who satisfy MCyR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy MCyR
Time frame: at 3 months and 6 months from administration
The number of subjects who satisfy MMR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy MMR
Time frame: at 3 months and 6 months from administration
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