Comparison · NCT04375397-e324dbf1
Ibrutinib 420 mg + SOC vs Placebo + SOC: Number of Participants With 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. Ibrutinib 420 mg + SOC vs Placebo + SOC: Number of Participants With Adverse Events. Trial comparisons, record NCT04375397-e324dbf1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04375397-e324dbf1
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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 | 0.545 | 0.347 | 0.731 | wilson | |
| Risk in group 2 | 0.5 | 0.314 | 0.686 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0455 | -0.227 | 0.308 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.628 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.376 | 3.83 | log | |
| Number needed to treat, for one more participant with the outcome on Ibrutinib 420 mg + SOC than on Placebo + SOC | 22 | 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 | Ibrutinib 420 mg + SOC | 420 mg ibrutinib administered once daily as three hard gelatin capsules (140 mg each) with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC) | 12 | 22 | OG000 |
| Group 2 | Placebo + SOC | Three hard gelatin placebo capsules administered once daily with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC) | 12 | 24 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events
- Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
- Time frame
- From first dose of study drug until 30 days following last dose of study drug (up to 70 days)
- Population
- Safety Population: all participants who received at least 1 dose of study drug
Source ClinicalTrials.gov
Trial
- Title
- Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury
- NCT number
- NCT04375397
- Phases
- PHASE2
- Conditions
- CoronaVirus Induced Disease-2019 (COVID-19)
- Interventions
- Ibrutinib, Placebo
- Lead sponsor
- AbbVie
- Results first posted
- 2022-06-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04375397?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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