Comparison · NCT03426124-sae
Retrospective vs Prospective: 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. Retrospective vs Prospective: serious adverse events. Trial comparisons, record NCT03426124-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03426124-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 | 0.101 | 0.0837 | 0.121 | wilson | |
| Risk in group 2 | 0.0798 | 0.0589 | 0.107 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0212 | -0.0112 | 0.0503 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 0.888 | 1.8 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.879 | 1.91 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Retrospective than on Prospective | 47.3 | 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 | Retrospective | Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.~EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. | 100 | 991 | EG000 |
| Group 2 | Prospective | Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.~EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. | 39 | 489 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit.
Source ClinicalTrials.gov
Trial
- Title
- An International Pulmonary Embolism Registry Using EKOS
- NCT number
- NCT03426124
- Phases
- Conditions
- Pulmonary Embolism and Thrombosis
- Interventions
- EkoSonic Endovascular System with thrombolytic
- Lead sponsor
- Boston Scientific Corporation
- Results first posted
- 2023-02-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03426124?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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