Agrylin Drug Use-Result Survey

Agrylin Capsules 0.5 mg Drug Use-Result Survey

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031210640

Enrollment

1826

Registered

2022-03-03

Start date

2014-11-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Thrombocythemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All cases who received treatment with anagrelide hydrochloride.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
1.Number of Participants Who Had One or More Adverse Events Time Frame: From start of study drug administration up to 12 months 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. 2.Number of Participants Who Had One or More Serious Adverse Event Time Frame: From start of study drug administration up to 12 months 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. 3.Number of Participants Who Had One or More Adverse Drug Reactions Time Frame: From start of study drug administration up to 12 months 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. 4.Number of Participants Who Had One or More Serious Adverse Drug Reactions Time Frame: From start of study drug administration up to 12 months 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. 5.Percentage of Participants Who Responded in Platelet Count Time Frame: Baseline, 1, 3, 6, 9 and 12 months after the start of study drug administration Percen	—

Measure

Time frame

1.Number of Participants Who Had One or More Adverse Events Time Frame: From start of study drug administration up to 12 months 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. 2.Number of Participants Who Had One or More Serious Adverse Event Time Frame: From start of study drug administration up to 12 months 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. 3.Number of Participants Who Had One or More Adverse Drug Reactions Time Frame: From start of study drug administration up to 12 months 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. 4.Number of Participants Who Had One or More Serious Adverse Drug Reactions Time Frame: From start of study drug administration up to 12 months 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. 5.Percentage of Participants Who Responded in Platelet Count Time Frame: Baseline, 1, 3, 6, 9 and 12 months after the start of study drug administration Percen

—

Secondary

Measure	Time frame
1.Percentage of Participants With at Least 50% Reduction in Platelet Count Time Frame: Baseline, 1, 3, 6, 9 and 12 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.	—

Contacts

Public ContactTrial Information Contact for Clinical

Takeda Pharmaceutical Company Limited

smb.Japanclinicalstudydisclosure@takeda.com+81-6-6204-2111

Outcome results