Comparison · NCT00451191-sae
100 Units Botulinum Toxin Type A vs 300 Units Botulinum Toxin Type A: 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. 100 Units Botulinum Toxin Type A vs 300 Units Botulinum Toxin Type A: serious adverse events. Trial comparisons, record NCT00451191-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00451191-sae
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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 | 0.103 | 0.0508 | 0.198 | wilson | |
| Risk in group 2 | 0.0758 | 0.0328 | 0.165 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0272 | -0.0765 | 0.131 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.454 | 4.07 | log | |
| Odds ratio, group 1 over group 2 | 1.4 | 0.421 | 4.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 100 Units Botulinum Toxin Type A than on 300 Units Botulinum Toxin Type A | 36.8 | from the risk difference interval | the interval includes no difference |
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 | 100 Units Botulinum Toxin Type A | botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area. | 7 | 68 | EG000 |
| Group 2 | 300 Units Botulinum Toxin Type A | botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area. | 5 | 66 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 months
Source ClinicalTrials.gov
Trial
- Title
- Botulinum Toxin Injection for the Management of BPH
- NCT number
- NCT00451191
- Phases
- PHASE2
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- botulinum toxin type A (BoNT/A)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2013-06-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00451191?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.
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