Comparison · NCT01757405-sae
Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI vs Arm 2: 1 x 270 Micrograms/kg rFVIIa BI: 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. Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI vs Arm 2: 1 x 270 Micrograms/kg rFVIIa BI: serious adverse events. Trial comparisons, record NCT01757405-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01757405-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 | 0.111 | 0.031 | 0.328 | wilson | |
| Risk in group 2 | 0.1 | 0.0279 | 0.301 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0111 | -0.205 | 0.24 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.174 | 7.09 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.142 | 8.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI than on Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 90 | 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 | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions. | 2 | 18 | EG000 |
| Group 2 | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion. | 2 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 months (throughout study period)
Source ClinicalTrials.gov
Trial
- Title
- Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
- NCT number
- NCT01757405
- Phases
- PHASE3
- Conditions
- Hemophilia A, Hemophilia B
- Interventions
- Recombinant Factor VIIa BI (rFVIIa BI), Recombinant Factor VIIa BI (rFVIIa BI)
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2016-10-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01757405?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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