Comparison · NCT04369469-sae
Group 1 - Ravulizumab + BSC vs Group 2 - BSC Alone: 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. Group 1 - Ravulizumab + BSC vs Group 2 - BSC Alone: serious adverse events. Trial comparisons, record NCT04369469-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04369469-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 | 0.622 | 0.535 | 0.702 | wilson | |
| Risk in group 2 | 0.567 | 0.448 | 0.679 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0549 | -0.0866 | 0.198 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.855 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.688 | 2.29 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1 - Ravulizumab + BSC than on Group 2 - BSC Alone | 18.2 | 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 | Group 1 - Ravulizumab + BSC | Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols. | 79 | 127 | EG000 |
| Group 2 | Group 2 - BSC Alone | Participants received medications, therapies, and interventions per standard hospital treatment protocols. | 38 | 67 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 through Day 90
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
- NCT number
- NCT04369469
- Phases
- PHASE3
- Conditions
- COVID-19 Severe Pneumonia, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Viral
- Interventions
- Ravulizumab, BSC
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2022-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04369469?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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