Comparison · NCT00803634-sae
Clevidipine vs Standard of Care: 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. Clevidipine vs Standard of Care: serious adverse events. Trial comparisons, record NCT00803634-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00803634-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 | 0.235 | 0.14 | 0.368 | wilson | |
| Risk in group 2 | 0.189 | 0.106 | 0.314 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0466 | -0.11 | 0.203 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.591 | 2.63 | log | |
| Odds ratio, group 1 over group 2 | 1.32 | 0.515 | 3.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Clevidipine than on Standard of Care | 21.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Clevidipine | Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h. | 12 | 51 | EG000 |
| Group 2 | Standard of Care | The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion. | 10 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
▪ Non-serious Adverse Events (AEs) assessed up to 7 days following randomization or discharge whichever occurred first, regardless of causal relationship to the study drug ▪ Serious AEs (SAEs) assessed up to 30 days post-randomization into the study.
Source ClinicalTrials.gov
Trial
- Title
- Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
- NCT number
- NCT00803634
- Phases
- PHASE3
- Conditions
- Hypertension, Heart Failure
- Interventions
- Clevidipine, Standard of Care IV antihypertensive
- Lead sponsor
- The Medicines Company
- Results first posted
- 2014-08-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00803634?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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