Urinary Bladder, Overactive
Conditions
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (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.
Detailed description
All the patients 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.
Interventions
Detrusitol® Capsule 2mg and 4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.
Exclusion criteria
* Patients not administered Detrusitol® Capsule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). | 52 weeks | 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. |
| Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | 52 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tolterodine Tartrate. Participants taking Tolterodine tartrate. | 343 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 31 |
Baseline characteristics
| Characteristic | Tolterodine Tartrate. |
|---|---|
| Age, Customized <65 years | 98 participants |
| Age, Customized >= 65 years | 245 participants |
| Complications Absent | 77 participants |
| Complications Present | 266 participants |
| Concomitant drug Absent | 87 participants |
| Concomitant drug Present | 256 participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 184 Participants |
| Target disease severity Mild | 135 participants |
| Target disease severity Moderate | 194 participants |
| Target disease severity Severe | 14 participants |
| Treatment Period 12 to 24 weeks | 44 participants |
| Treatment Period 24 to 52 weeks | 88 participants |
| Treatment Period 52 to 76 weeks | 172 participants |
| Treatment Period 76 to 104 weeks | 31 participants |
| Treatment Period Less than 12 weeks | 1 participants |
| Treatment Period Over 104 weeks | 7 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 343 |
| serious Total, serious adverse events | 1 / 343 |
Outcome results
Primary
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted 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. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time frame: 52 weeks
Population: Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine Tartrate. | Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). | Glaucoma | 1 participants |
| Tolterodine Tartrate. | Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). | Death | 1 participants |
| Tolterodine Tartrate. | Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). | Abdominal discomfort | 1 participants |
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.
Time frame: 52 weeks
Population: Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate. | Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | 25 participants |