Comparison · NCT00803101-sae
Beriplex® P/N vs Fresh Frozen Plasma: 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. Beriplex® P/N vs Fresh Frozen Plasma: serious adverse events. Trial comparisons, record NCT00803101-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00803101-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 | 0.25 | 0.171 | 0.35 | wilson | |
| Risk in group 2 | 0.261 | 0.181 | 0.362 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0114 | -0.139 | 0.117 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.957 | 0.578 | 1.58 | log | |
| Odds ratio, group 1 over group 2 | 0.942 | 0.478 | 1.85 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Beriplex® P/N than on Fresh Frozen Plasma | 88 | 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 | Beriplex® P/N | Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight. | 22 | 88 | EG000 |
| Group 2 | Fresh Frozen Plasma | Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight | 23 | 88 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.
Source ClinicalTrials.gov
Trial
- Title
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
- NCT number
- NCT00803101
- Phases
- PHASE3
- Conditions
- Reversal of Coagulopathy
- Interventions
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Lead sponsor
- CSL Behring
- Results first posted
- 2014-02-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00803101?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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