Drug Use Investigation for Toviaz
- Registration Number
- NCT01936870
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2521
- Patients prescribed fesoterodine (Toviaz).
- There are no exclustion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fesoterodine (Toviaz) Fesoterodine (Toviaz) -
- Primary Outcome Measures
Name Time Method Clinical Efficacy Rate 12 Weeks Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.
Number of Participants With Treatment-Related Adverse Events 12 Weeks A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg 12 Weeks A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert 12 Weeks A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator.
Satisfaction Rate 12 Weeks Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed.
Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks Baseline, 12 Weeks Overactive Bladder Symptom Score (OABSS) was defined as the sum score (0 to 15) of the following four OAB symptoms: daytime frequency (2 at maximum), nighttime frequency (3 at maximum), urgency (5 at maximum), and urgency incontinence (5 at maximum). Higher score indicates worse symptoms. Mean change from baseline in the OABSS at 12 weeks was presented along with the corresponding standard deviation.
Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors 12 Weeks Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
Number of Participants With Treatment-Related Serious Adverse Events 12 Weeks A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator.
Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors 12 Weeks Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin.
Number of Participants With Adverse Events Related to Cognitive Function Disorder 12 Weeks An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ).
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks Baseline, 12 Weeks Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation.