Comparison · NCT02554773-sae
Original Dose Regimen (SAS 1) vs AT-Based Dose Regimen (SAS 2): 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. Original Dose Regimen (SAS 1) vs AT-Based Dose Regimen (SAS 2): serious adverse events. Trial comparisons, record NCT02554773-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02554773-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 | 0.382 | 0.239 | 0.55 | wilson | |
| Risk in group 2 | 0.0556 | 0.00988 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | 0.327 | 0.0791 | 0.5 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 6.88 | 0.977 | 48.5 | log | |
| Odds ratio, group 1 over group 2 | 10.5 | 1.25 | 88.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Original Dose Regimen (SAS 1) than on AT-Based Dose Regimen (SAS 2) | 3.06 | 2 | 12.6 | from the risk difference interval |
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 | Original Dose Regimen (SAS 1) | Participants received fitusiran 50 mg or 80 mg SC injection QM under the original dose and regimen. | 13 | 34 | EG000 |
| Group 2 | AT-Based Dose Regimen (SAS 2) | Participants received fitusiran 50 mg QM, 80 mg QM or 50 mg Q2M SC injection under recommended AT-based dose regimen. | 1 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- TEAEs data was collected from first dose of study drug (Day 1) up to end of the study (SAS 1: up to 76 months and SAS 2: up to 40 months).
Source ClinicalTrials.gov
Trial
- Title
- An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B
- NCT number
- NCT02554773
- Phases
- PHASE1, PHASE2
- Conditions
- Hemophilia A, Hemophilia B
- Interventions
- Fitusiran (SAR439774)
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2024-06-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02554773?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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