Comparison · NCT04351243-sae
Gimsilumab 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. Gimsilumab vs Placebo: serious adverse events. Trial comparisons, record NCT04351243-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04351243-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 | 0.416 | 0.329 | 0.508 | wilson | |
| Risk in group 2 | 0.402 | 0.316 | 0.494 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0141 | -0.113 | 0.14 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.756 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.623 | 1.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Gimsilumab than on Placebo | 70.7 | 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 | Gimsilumab | Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb) | 47 | 113 | EG000 |
| Group 2 | Placebo | Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline | 45 | 112 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events through Day 43
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
- NCT number
- NCT04351243
- Phases
- PHASE2
- Conditions
- COVID-19
- Interventions
- Gimsilumab, Placebo
- Lead sponsor
- Kinevant Sciences GmbH
- Results first posted
- 2021-12-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04351243?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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