N/A
Completed N=11,157
Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Source: ClinicalTrials.gov NCT01488578 ↗Enrolled (actual)
11,157
Serious AEs
0.1%
Results posted
Jun 2012
Primary outcomePrimary: Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). — 984 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). |
984 | — |
| PRIMARY Number of Participants Which Was Evaluated as "Degree of Satisfaction". |
5609; 1033; 963; 175 | — |
| PRIMARY Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. |
6536; 1244 | — |
| PRIMARY Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. |
344; 194; 166 | — |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs |
3483; 3053 | <0.001 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies |
317; 6219 | =0.032 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Gender |
2745; 3791 | <0.001 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Complications |
3960; 2576 | <0.001 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Age |
2060; 4476 | <0.001 sig |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy |
319; 130 | <0.001 sig |
| SECONDARY Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants |
18; 11; 10; 10; 6; 5 | — |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder |
2426; 3709; 401 | =0.006 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency |
5529; 829 | <0.001 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) |
370; 882; 1380; 3523 | =0.015 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day |
1670; 710; 254 | <0.001 sig |
| SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment |
698; 5753 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.
Exclusion Criteria
- Subjects who have been prescribed Detrusitol Capsule before.
Data sourced from ClinicalTrials.gov (NCT01488578). 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.