Comparison · NCT00209560-sae
Fospropofol Disodium vs Midazolam: 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. Fospropofol Disodium vs Midazolam: serious adverse events. Trial comparisons, record NCT00209560-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00209560-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 | 0.00826 | 0.00146 | 0.0453 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0838 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00826 | -0.0758 | 0.0453 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Fospropofol Disodium than on Midazolam | 121 | 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 | Fospropofol Disodium | 525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed. | 1 | 121 | EG000 |
| Group 2 | Midazolam | 0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed. | 0 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
- NCT number
- NCT00209560
- Phases
- PHASE3
- Conditions
- Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
- Interventions
- fospropofol disodium
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2012-06-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00209560?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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