Agrylin Drug Use-Result Survey

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.

Percentage of participants who responded in platelet count was assessed. A response was defined as platelet counts to <60 x10^4 platelet/mcrL beyond 3 months after the start of study drug administration.

Percentage of participants with normalization in platelet count was assessed. Normalization was defined as platelet counts to <40 x10^4 platelets/mcrL beyond 3 months after the start of study drug administration.

Participants who achieved at least 50% reduction in platelet count from their baseline during the 1-year observation period was assessed.