Comparison · NCT03078582-sae
Cohort A (Treatment Naive) vs Cohort B (Previously on Eculizumab): 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. Cohort A (Treatment Naive) vs Cohort B (Previously on Eculizumab): serious adverse events. Trial comparisons, record NCT03078582-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03078582-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 | 0.2 | 0.0567 | 0.51 | wilson | |
| Risk in group 2 | 0.0625 | 0.0111 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | 0.138 | -0.126 | 0.452 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.2 | 0.332 | 30.9 | log | |
| Odds ratio, group 1 over group 2 | 3.75 | 0.293 | 48 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort A (Treatment Naive) than on Cohort B (Previously on Eculizumab) | 7.27 | 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 | Cohort A (Treatment Naive) | 0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC | 2 | 10 | EG000 |
| Group 2 | Cohort B (Previously on Eculizumab) | 0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC | 1 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through Week 12 of the study
Source ClinicalTrials.gov
Trial
- Title
- Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients
- NCT number
- NCT03078582
- Phases
- PHASE2
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Interventions
- Zilucoplan (RA101495)
- Lead sponsor
- Ra Pharmaceuticals
- Results first posted
- 2020-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03078582?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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