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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
All the subjects whom an investigator prescribes the first Detrusitol Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolterodine tartrate. | Subjects taking Tolterodine tartrate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolterodine tartrate | Drug | Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | 12 weeks |
| Number of Participants Which Was Evaluated as "Degree of Satisfaction". | Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above. | 12 week |
| Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period. | 12 week |
| Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher. | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Tolterodine Tartrate | Participants taking Tolterodine tartrate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tolterodine Tartrate | Participants taking Tolterodine tartrate according to Japanese Package Insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol. | Posted | Number | participants | 12 weeks |
|
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The same event may appear as both an AE and a SAE. 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 | Tolterodine Tartrate | Participants taking Tolterodine tartrate according to Japanese Package Insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary retention | Renal and urinary disorders | MedDRA/J13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thirst | General disorders | MedDRA/J13.1 | 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 |
|---|---|
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor. |
| 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Gender | Number of participants with responders of tolterodine to determine whether male or female is significant risk factor. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Complications | Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Age | Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor. | 12 week |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor. | 12 week |
| Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder | Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency | Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day | Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor. | 12 week |
| Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment | Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor. | 12 week |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Target disease severity | The severity of Overactive Bladder which was diagnosed by investigator. | Number | participants |
|
| Complications | Number | participants |
|
| Concomitant drug | Number | participants |
|
| Starting dose | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Primary | Number of Participants Which Was Evaluated as "Degree of Satisfaction". | Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
| Primary | Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period. | The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated. Number of participants evaluable for which was evaluated "effect". | Posted | Number | participants | 12 week |
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Gender | Number of participants with responders of tolterodine to determine whether male or female is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Complications | Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Age | Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor. | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol. | Posted | Number | events | 12 week |
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder | Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency | Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day | Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Secondary | Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment | Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor. | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | 12 week |
|
|
|
|
| Primary | Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher. | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol. | Posted | Number | events | 12 week |
|
|
|
| 12 |
| 9,321 |
| 703 |
| 9,321 |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA/J13.1 | 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 |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| Title | Measurements |
|---|---|
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| Abdominal distension |
|
| Pruritus |
|
| Stomatitis |
|
| Malaise |
|
| Title | Measurements |
|---|---|
|