The objective of this survey is to collect data to evaluate the safety and efficacy of anagrelide hydrochloride in the post-marketing phase in participants diagnosed with Essential Thrombocythemia (ET).
Anagrelide hydrochloride Drug Use-Result Survey
Study Type
OBSERVATIONAL
Enrollment
1,826
Number of Participants Who Had One or More Adverse Events
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.
Time frame: From start of study drug administration up to 12 months
Number of Participants Who Had One or More Serious Adverse Event
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.
Time frame: From start of study drug administration up to 12 months
Number of Participants Who Had One or More Adverse Drug Reactions
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.
Time frame: From start of study drug administration up to 12 months
Number of Participants Who Had One or More Serious Adverse Drug Reactions
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.
Time frame: From start of study drug administration up to 12 months
Percentage of Participants Who Responded in Platelet Count
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.
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Gamagori-city
Gamagōri, Aichi-ken, Japan
Handa City
Handa, Aichi-ken, Japan
Hekinan-city
Hekinan, Aichi-ken, Japan
Ichinomiya-city
Ichinomiya, Aichi-ken, Japan
Ichinomiya-city
Ichinomiya, Aichi-ken, Japan
Ichinomiya-city
Ichinomiya, Aichi-ken, Japan
Komaki-city
Komaki, Aichi-ken, Japan
Nagakute-city
Nagakute, Aichi-ken, Japan
Nagoya-city
Nagoya, Aichi-ken, Japan
Nagoya-city
Nagoya, Aichi-ken, Japan
...and 478 more locations
Time frame: From 3 months after the start of study drug administration, up to 12 months
Percentage of Participants With Normalization in Platelet Count
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.
Time frame: From 3 months after the start of study drug administration, up to 12 months
Percentage of Participants With at Least 50% Reduction in Platelet Count
Participants who achieved at least 50% reduction in platelet count from their baseline during the 1-year observation period was assessed.
Time frame: From start of study drug administration up to 12 months