Comparison · NCT00708435-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 NCT00708435-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00708435-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 | 0.311 | 0.229 | 0.405 | wilson | |
| Risk in group 2 | 0.239 | 0.168 | 0.327 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0721 | -0.0476 | 0.19 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.837 | 2.03 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 0.784 | 2.64 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Beriplex® P/N than on Fresh Frozen Plasma | 13.9 | 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 | 32 | 103 | EG000 |
| Group 2 | Fresh Frozen Plasma | Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight | 26 | 109 | 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 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
- NCT number
- NCT00708435
- Phases
- PHASE3
- Conditions
- Blood Coagulation Disorders, Acute Major Bleeding
- Interventions
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Lead sponsor
- CSL Behring
- Results first posted
- 2013-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00708435?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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