This study is to determine the following information. 1. The occurrence of adverse drug reactions in clinical settings. 2. Factors potentially impacting safety, effectiveness, and other aspects.
This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron): 1. The occurrence of adverse drug reactions in clinical settings. 2. Factors potentially impacting safety, effectiveness, and other aspects. Items of Particular Interest: * Safety and effectiveness in patients with hepatic impairment and patients with renal impairment. * Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs). * The occurrence of cardiovascular adverse events. * The occurrence of adverse events related to increased intraocular pressure. * The occurrence of urinary retention
Study Type
OBSERVATIONAL
Enrollment
10,711
Oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Occurrence of adverse events and adverse drug reactions
Time frame: For 12 weeks
Changes in OABSS (overactive bladder symptom score)
Time frame: baseline and at 12 weeks (or last observation period)
Items of particular interest
Time frame: baseline and at 12 weeks (or last observation period)
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Unnamed facility
Kyushu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan