N/A
N=2,492
Drug Use Investigation for Toviaz
Overactive Bladder (OAB)
Bottom Line
View on ClinicalTrials.gov: NCT01936870 ↗Enrolled (actual)
2,492
Serious AEs
0.5%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 415 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Fesoterodine (Toviaz) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2016
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 | — |
Summary
The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
Eligibility Criteria
Inclusion Criteria
- Patients prescribed fesoterodine (Toviaz).
Exclusion Criteria
- There are no exclustion criteria
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.