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The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study.
A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects prescribed IMIGRAN | Subjects with migraine disorders prescribed IMIGRAN during study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of incidence of adverse events in subjects with migraine disorders | Adverse event (AE), diagnosis or symptom, date of onset, outcome, date of outcome, seriousness, reason for judgement of "serious", intensity, relationship to IMIGRAN, other factors suspected to have relationship to AE | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of arrhythmia | Occurrence of arrhythmia is investigated throughout study period. | 2 months |
| Occurrence of angina pectoris | Occurrence of angina pectoris is investigated throughout study period. |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female Japanese subjects with migraine disorders who were considered appropriate to prescribe sumatriptan tablet according to the prescribing information were eligible for this surveillance study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| 2 months |
| Occurrence of myocardial infarction | Occurrence of myocardial infarction is investigated throughout study period. | 2 months |
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |