Overactive Bladder (OAB)
Conditions
Keywords
Toviaz, Fesoterodine, Post marketing surveillance, Japanese, Overactive Bladder, OAB, Good post marketing practice, Regulatory Post Marketing Commitment Plan
Brief summary
The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
Interventions
DRUGFesoterodine (Toviaz)
Fesoterodine 4 mg or 8 mg orally. Toviaz will be dosed according to labeling. The administration and duration of therapy will be determined by the treating physician to meet the patient's needs for treatment.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients prescribed fesoterodine (Toviaz).
Exclusion criteria
* There are no exclustion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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. |
| 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 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine Fumarate Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms. | 2,303 |
| Total | 2,303 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No Drug Administration | 1 |
| Overall Study | No Visit After Treatment | 176 |
| Overall Study | Protocol Violation | 12 |
Baseline characteristics
| Characteristic | Fesoterodine Fumarate |
|---|---|
| Age, Customized >=15 and <65 years | 529 Participants |
| Age, Customized <15 years | 1 Participants |
| Age, Customized ˃=65 years | 1773 Participants |
| Sex: Female, Male Female | 1228 Participants |
| Sex: Female, Male Male | 1075 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 361 / 2,303 |
| serious Total, serious adverse events | 12 / 2,303 |
Outcome results
Primary
Clinical Efficacy Rate
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.
Time frame: 12 Weeks
Population: The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine Fumarate | Clinical Efficacy Rate | 74.8 Percentage of participants |
Primary
Number of Participants With Treatment-Related Adverse Events
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.
Time frame: 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events | 415 Participants |
Secondary
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 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.
Time frame: Baseline, 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Participants with observed change in MMSE score were included in table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine Fumarate | Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks | 0.4 Scale | Standard Deviation 1.29 |
Secondary
Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 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.
Time frame: Baseline, 12 Weeks
Population: The effectiveness analysis set comprised of participants from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use. Participants with observed change in OABSS were included in table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine Fumarate | Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks | -3.4 Scale | Standard Deviation 3.04 |
Secondary
Number of Participants With Adverse Events Related to Cognitive Function Disorder
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).
Time frame: 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Adverse Events Related to Cognitive Function Disorder | 2 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors
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.
Time frame: 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Number Analyzed signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors | Received Concomitant CYP2D6 Inhibitors | 11 Participants |
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors | Not Received Concomitant CYP2D6 Inhibitors | 404 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors
Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin.
Time frame: 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Number Analyzed signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors | Received Concomitant CYP3A4 Inhibitors | 6 Participants |
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors | Not Received Concomitant CYP3A4 Inhibitors | 409 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg
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.
Time frame: 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Number Analyzed signifies those participants who were evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg | From 4 mg to 8 mg | 53 Participants |
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg | 4 mg | 330 Participants |
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg | 8 mg | 32 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
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.
Time frame: 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 27 Participants |
Secondary
Number of Participants With Treatment-Related Serious Adverse Events
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.
Time frame: 12 Weeks
Population: The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Treatment-Related Serious Adverse Events | 8 Participants |
Secondary
Satisfaction Rate
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.
Time frame: 12 Weeks
Population: The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine Fumarate | Satisfaction Rate | 59.0 Percentage of participants |