N/A Completed N=2,492

Drug Use Investigation for Toviaz

Overactive Bladder (OAB)

Source: ClinicalTrials.gov NCT01936870 ↗

Enrolled (actual)

2,492

Serious AEs

0.5%

Results posted

Apr 2017

Primary outcomePrimary: Number of Participants With Treatment-Related Adverse Events — 415 Participants

Summary

The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Related Adverse Events	415	—
PRIMARY Clinical Efficacy Rate	74.8	—
SECONDARY Number of Participants With Treatment-Related Serious Adverse Events	8	—
SECONDARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	27	—
SECONDARY Number of Participants With Adverse Events Related to Cognitive Function Disorder	2	—
SECONDARY Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks	0.4	—
SECONDARY Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors	6; 409	—
SECONDARY Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors	11; 404	—
SECONDARY Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg	53; 330; 32	—
SECONDARY Satisfaction Rate	59.0	—
SECONDARY Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks	-3.4	—

Eligibility Criteria

Inclusion Criteria

Patients prescribed fesoterodine (Toviaz).

Exclusion Criteria

There are no exclustion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01936870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.