Comparison · NCT00596752-sae
Alprostadil vs Placebo: 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. Alprostadil vs Placebo: serious adverse events. Trial comparisons, record NCT00596752-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00596752-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 | 0.209 | 0.173 | 0.251 | wilson | |
| Risk in group 2 | 0.147 | 0.116 | 0.183 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0626 | 0.0108 | 0.114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.43 | 1.06 | 1.92 | log | |
| Odds ratio, group 1 over group 2 | 1.54 | 1.08 | 2.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Alprostadil than on Placebo | 16 | 8.76 | 92.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Alprostadil | Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~* Pharmaceutical Form: solution for infusion~* Concentration: 40 μg b.d.~* Route of Administration: intravenous infusion | 87 | 416 | EG000 |
| Group 2 | Placebo | Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~* Pharmaceutical Form: solution for infusion~* Concentration: 40 μg b.d.~* Route of Administration: intravenous infusion | 62 | 423 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected during the course of the study from Study Day 0 up to Study Day 196.
Source ClinicalTrials.gov
Trial
- Title
- Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
- NCT number
- NCT00596752
- Phases
- PHASE4
- Conditions
- Peripheral Arterial Occlusive Disease
- Interventions
- Alprostadil, Placebo
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Results first posted
- 2014-08-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00596752?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
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