N/A
Completed N=374
Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT00795509 ↗
Enrolled (actual)
374
Serious AEs
0.3%
Results posted
Jul 2012
Primary outcomePrimary: Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). — 1; 1; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). |
1; 1; 1 | — |
| PRIMARY Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). |
25 | — |
Eligibility Criteria
Inclusion Criteria
- Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.
Exclusion Criteria
- Patients not administered Detrusitol® Capsule.
Data sourced from ClinicalTrials.gov (NCT00795509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.