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The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine (Toviaz) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine (Toviaz) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients prescribed fesoterodine (Toviaz) by investigators involved in protocol A0221096.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 2492 participants completed this study. Of the 2492 participants, 189 participants were excluded from the baseline analysis due to following reasons: no visit after treatment (176 participants), protocol violation (12 participants), and no drug administration (1 participant).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
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The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| 12 Weeks |
| 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. | 12 Weeks |
| 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). | 12 Weeks |
| 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. | Baseline, 12 Weeks |
| 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. | 12 Weeks |
| 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. | 12 Weeks |
| 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. | 12 Weeks |
| 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. | 12 Weeks |
| 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. | Baseline, 12 Weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Scale | Baseline, 12 Weeks |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Scale | Baseline, 12 Weeks |
|
|
|
| 12 |
| 2,303 |
| 361 |
| 2,303 |
| Loss of consciousness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Residual urine volume increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 8 mg |
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