Comparison · NCT04362111-sae
Anakinra Group vs Control Group: 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. Anakinra Group vs Control Group: serious adverse events. Trial comparisons, record NCT04362111-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04362111-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 | 0.6 | 0.357 | 0.802 | wilson | |
| Risk in group 2 | 0.467 | 0.248 | 0.699 | wilson | |
| Risk difference, group 1 minus group 2 | 0.133 | -0.202 | 0.431 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.651 | 2.54 | log | |
| Odds ratio, group 1 over group 2 | 1.71 | 0.403 | 7.29 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Anakinra Group than on Control Group | 7.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Anakinra Group | The active treatment group will receive anakinra 100 mg subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to 100 mg twice daily for the remaining 5 days.~Anakinra: The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days | 9 | 15 | EG000 |
| Group 2 | Control Group | The control group will receive normal saline placebo subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to twice daily for the remaining 5 days.~Normal saline: The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days | 7 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 60 days
Source ClinicalTrials.gov
Trial
- Title
- Early Treatment of Cytokine Storm Syndrome in Covid-19
- NCT number
- NCT04362111
- Phases
- PHASE3
- Conditions
- Cytokine Storm, COVID-19
- Interventions
- Anakinra, Normal saline
- Lead sponsor
- University of Alabama at Birmingham
- Results first posted
- 2023-08-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04362111?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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