Agrylin Drug Use-Result Survey

Study Overview
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Brief Summary
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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).

Detailed Description
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Anagrelide hydrochloride Drug Use-Result Survey

Official Title
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Agrylin Capsules 0.5 mg Drug Use-Result Survey

Conditions
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Essential Thrombocythemia (ET)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All cases who received treatment with Agrylin. Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anagrelide hydrochloride<br>Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | From 3 months after the start of study drug administration, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From start of study drug administration up to 12 months |