Comparison · NCT03151993-sae
Recombinant Staphylokinase vs Actilyse: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Recombinant Staphylokinase vs Actilyse: serious adverse events. Trial comparisons, record NCT03151993-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03151993-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 | 0.131 | 0.0881 | 0.19 | wilson | |
| Risk in group 2 | 0.226 | 0.169 | 0.295 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0952 | -0.176 | -0.0131 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.579 | 0.358 | 0.935 | log | |
| Odds ratio, group 1 over group 2 | 0.516 | 0.29 | 0.917 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Recombinant Staphylokinase than on Actilyse | 10.5 | 5.67 | 76.2 | from the risk difference interval |
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 | Recombinant Staphylokinase | Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds~Recombinant staphylokinase: 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds | 22 | 168 | EG000 |
| Group 2 | Actilyse | Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)~Alteplase: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg) | 38 | 168 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 90 days after fibronolysis
Source ClinicalTrials.gov
Trial
- Title
- Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS
- NCT number
- NCT03151993
- Phases
- PHASE3
- Conditions
- Ischemic Stroke
- Interventions
- Recombinant staphylokinase, Alteplase
- Lead sponsor
- Supergene, LLC
- Results first posted
- 2025-04-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03151993?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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