Comparison · NCT01107392-sae
Botulinum Toxin Type A vs Placebo (Normal Saline): serious adverse events
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. Botulinum Toxin Type A vs Placebo (Normal Saline): serious adverse events. Trial comparisons, record NCT01107392-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01107392-sae
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 | 0.0316 | 0.0136 | 0.0719 | wilson | |
| Risk in group 2 | 0.051 | 0.026 | 0.0973 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0193 | -0.0691 | 0.0281 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.621 | 0.208 | 1.86 | log | |
| Odds ratio, group 1 over group 2 | 0.609 | 0.195 | 1.9 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Botulinum Toxin Type A than on Placebo (Normal Saline) | 51.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Botulinum Toxin Type A | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. | 5 | 158 | EG000 |
| Group 2 | Placebo (Normal Saline) | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. | 8 | 157 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- NCT number
- NCT01107392
- Phases
- PHASE2
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- botulinum toxin Type A, Normal saline
- Lead sponsor
- Allergan
- Results first posted
- 2014-04-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01107392?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/NCT01107392-sae