Comparison · NCT02210091-sae
BAX 855 Safety Analysis Set vs ADVATE Received Before BAX 855: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. BAX 855 Safety Analysis Set vs ADVATE Received Before BAX 855: serious adverse events. Trial comparisons, record NCT02210091-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02210091-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 | 0.0455 | 0.0156 | 0.125 | wilson | |
| Risk in group 2 | 0 | 0 | 0.11 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0455 | -0.0688 | 0.125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on BAX 855 Safety Analysis Set than on ADVATE Received Before BAX 855 | 22 | 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 | BAX 855 Safety Analysis Set | Participants who received at least 1 dose of BAX 855. | 3 | 66 | EG000 |
| Group 2 | ADVATE Received Before BAX 855 | Participants who received at least 1 dose of ADVATE prior to receiving BAX 855 in the PK part of the study. | 0 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Throughout the study period of 1 year (8-10 months per participant)
Source ClinicalTrials.gov
Trial
- Title
- BAX 855 Pediatric Study
- NCT number
- NCT02210091
- Phases
- PHASE3
- Conditions
- Hemophilia A
- Interventions
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII, PEGylated Recombinant Factor VIII
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2016-12-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02210091?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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