This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.
Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.
Study Type
OBSERVATIONAL
Enrollment
508
Any dose of Fesoterodine
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment
Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).
Time frame: Baseline up to 28 days after last dose
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