Comparison · NCT05568888-sae
BE1116 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. BE1116 vs Placebo: serious adverse events. Trial comparisons, record NCT05568888-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05568888-sae
On this page
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 | 0.328 | 0.293 | 0.366 | wilson | |
| Risk in group 2 | 0.268 | 0.235 | 0.304 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0605 | 0.00971 | 0.111 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 1.03 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 1.34 | 1.05 | 1.71 | log | |
| Number needed to harm, for one more participant with a serious adverse event on BE1116 than on Placebo | 16.5 | 9.01 | 103 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BE1116 | Participants received a single administration of BE1116 via IV administration on Day 1. | 203 | 618 | EG000 |
| Group 2 | Placebo | Participants received IV administration of placebo matched to BE1116. | 168 | 627 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 30 days after randomization
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
- NCT number
- NCT05568888
- Phases
- PHASE3
- Conditions
- Traumatic Injury
- Interventions
- BE1116, Placebo
- Lead sponsor
- CSL Behring
- Results first posted
- 2025-11-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05568888?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT05568888-sae