Comparison · NCT04404361-sae
Pacritinib and SOC vs Placebo and SOC: 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. Pacritinib and SOC vs Placebo and SOC: serious adverse events. Trial comparisons, record NCT04404361-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04404361-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 | 0.208 | 0.139 | 0.3 | wilson | |
| Risk in group 2 | 0.327 | 0.243 | 0.423 | wilson | |
| Risk difference, group 1 minus group 2 | -0.118 | -0.237 | 0.0057 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.638 | 0.395 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 0.542 | 0.285 | 1.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pacritinib and SOC than on Placebo and SOC | 8.45 | 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 | Pacritinib and SOC | Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC~Pacritinib: 100 mg capsules | 20 | 96 | EG000 |
| Group 2 | Placebo and SOC | 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC~Placebo: Placebo capsules matching pacritinib 100 mg capsules | 33 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo.
Source ClinicalTrials.gov
Trial
- Title
- PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
- NCT number
- NCT04404361
- Phases
- PHASE2
- Conditions
- COVID19, COVID-19, COVID
- Interventions
- Pacritinib, Placebo
- Lead sponsor
- CTI BioPharma
- Results first posted
- 2024-06-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04404361?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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