Comparison · NCT01263925-sae
Alprostadil vs Pentoxifylline: 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 Pentoxifylline: serious adverse events. Trial comparisons, record NCT01263925-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01263925-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 | 0.0688 | 0.0445 | 0.105 | wilson | |
| Risk in group 2 | 0.0596 | 0.0376 | 0.0934 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00919 | -0.0324 | 0.0516 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.613 | 2.17 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.593 | 2.29 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Alprostadil than on Pentoxifylline | 109 | 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 | Alprostadil | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets. | 19 | 276 | EG000 |
| Group 2 | Pentoxifylline | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets. | 17 | 285 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Source ClinicalTrials.gov
Trial
- Title
- Prostaglandin E1 in Outpatients With Intermittent Claudication
- NCT number
- NCT01263925
- Phases
- PHASE3
- Conditions
- Stage II Peripheral Arterial Occlusive Disease, Intermittent Claudication Fontaine Stage II PAOD
- Interventions
- Alprostadil (Prostaglandin E1), Pentoxifylline, Placebo to Pentoxifylline oral, Placebo to Alprostadil (Prostaglandin E1) intravenous
- Lead sponsor
- UCB Pharma
- Results first posted
- 2012-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01263925?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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