Comparison · NCT04362813-sae
Canakinumab vs Placebo: 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. Canakinumab vs Placebo: serious adverse events. Trial comparisons, record NCT04362813-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04362813-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 | 0.209 | 0.161 | 0.267 | wilson | |
| Risk in group 2 | 0.238 | 0.187 | 0.298 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0288 | -0.106 | 0.0484 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.879 | 0.622 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.847 | 0.543 | 1.32 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Canakinumab than on Placebo | 34.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Canakinumab | Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1. | 47 | 225 | EG000 |
| Group 2 | Placebo | 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1. | 53 | 223 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from first dose of study treatment until end of study at day 127
Source ClinicalTrials.gov
Trial
- Title
- Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
- NCT number
- NCT04362813
- Phases
- PHASE3
- Conditions
- Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
- Interventions
- Canakinumab, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2021-08-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04362813?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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