Comparison · NCT01488578-df1e0f06
With BPH vs Without BPH: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. With BPH vs Without BPH: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy. Trial comparisons, record NCT01488578-df1e0f06. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01488578-df1e0f06
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.145 | 0.131 | 0.16 | wilson | |
| Risk in group 2 | 0.0701 | 0.0593 | 0.0826 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0747 | 0.0559 | 0.0934 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.07 | 1.7 | 2.51 | log | |
| Odds ratio, group 1 over group 2 | 2.25 | 1.81 | 2.78 | log | |
| Number needed to treat, for one more participant with the outcome on With BPH than on Without BPH | 13.4 | 10.7 | 17.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | With BPH | Participants with complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert. | 319 | 2,203 | OG000 |
| Group 2 | Without BPH | Participants without complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert. | 130 | 1,855 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy
- Description
- 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.
- Time frame
- 12 week
- Population
- The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Source ClinicalTrials.gov
Trial
- Title
- Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
- NCT number
- NCT01488578
- Phases
- Conditions
- Overactive Bladder
- Interventions
- Tolterodine tartrate
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2012-06-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01488578?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01488578-df1e0f06