Comparison · NCT03417102-sae
Bypassing Agents (BPA) On-demand vs Fitusiran 80 mg Prophylaxis: 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. Bypassing Agents (BPA) On-demand vs Fitusiran 80 mg Prophylaxis: serious adverse events. Trial comparisons, record NCT03417102-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03417102-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 | 0.263 | 0.118 | 0.488 | wilson | |
| Risk in group 2 | 0.171 | 0.0853 | 0.313 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0924 | -0.111 | 0.333 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.54 | 0.561 | 4.23 | log | |
| Odds ratio, group 1 over group 2 | 1.73 | 0.47 | 6.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bypassing Agents (BPA) On-demand than on Fitusiran 80 mg Prophylaxis | 10.8 | 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 | Bypassing Agents (BPA) On-demand | Participants received On-demand BPAs (use of these agents, as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion from Day 1 for treatment of breakthrough bleeding episodes, up to a total of 9 months. | 5 | 19 | EG000 |
| Group 2 | Fitusiran 80 mg Prophylaxis | Participants received Fitusiran 80 mg subcutaneously (SC) as prophylaxis once monthly from Day 1, along with the on-demand BPAs (per investigator's discretion and within bleeding dosing guidelines) for treatment of breakthrough bleeding episodes, up to a total of 9 months. | 7 | 41 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AE data were collected from Baseline (Day 1) up to 15 months (i.e., 9 months treatment period + 6-months follow-up).
Source ClinicalTrials.gov
Trial
- Title
- A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors
- NCT number
- NCT03417102
- Phases
- PHASE3
- Conditions
- Hemophilia A, Hemophilia B
- Interventions
- fitusiran, Bypassing agents
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2021-12-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03417102?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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