Comparison · NCT00623480-sae
Recombinant Factor VIII Prophylaxis Treatment vs Recombinant Factor VIII On-demand Treatment: 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. Recombinant Factor VIII Prophylaxis Treatment vs Recombinant Factor VIII On-demand Treatment: serious adverse events. Trial comparisons, record NCT00623480-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00623480-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 | 0.214 | 0.117 | 0.359 | wilson | |
| Risk in group 2 | 0.262 | 0.153 | 0.411 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0476 | -0.225 | 0.134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.818 | 0.379 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 0.769 | 0.28 | 2.11 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Recombinant Factor VIII Prophylaxis Treatment than on Recombinant Factor VIII On-demand Treatment | 21 | 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 | Recombinant Factor VIII Prophylaxis Treatment | Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater. | 9 | 42 | EG000 |
| Group 2 | Recombinant Factor VIII On-demand Treatment | Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations. | 11 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization until Month 37.
Source ClinicalTrials.gov
Trial
- Title
- Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
- NCT number
- NCT00623480
- Phases
- PHASE3
- Conditions
- Hemophilia A
- Interventions
- Recombinant Factor VIII (Kogenate FS, BAY14-2222), Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Lead sponsor
- Bayer
- Results first posted
- 2013-08-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00623480?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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