Comparison · NCT04115293-sae
Zilucoplan 0.3 mg/kg vs Placebo: 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. Zilucoplan 0.3 mg/kg vs Placebo: serious adverse events. Trial comparisons, record NCT04115293-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04115293-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 | 0.128 | 0.0729 | 0.215 | wilson | |
| Risk in group 2 | 0.148 | 0.0884 | 0.237 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0198 | -0.124 | 0.0853 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.866 | 0.411 | 1.83 | log | |
| Odds ratio, group 1 over group 2 | 0.846 | 0.356 | 2.01 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Zilucoplan 0.3 mg/kg than on Placebo | 50.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Zilucoplan 0.3 mg/kg | Participants self-administered zilucoplan (RA101495) 0.3 milligrams/kilogram/day (mg/kg/day) SC injection during 12-week Treatment Period. | 11 | 86 | EG001 |
| Group 2 | Placebo | Participants self-administered zilucoplan (RA101495) matching placebo as subcutaneous (SC) injection during 12-week Treatment Period. | 13 | 88 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline (Day 1) to Safety follow-up visit (19 Weeks [12 weeks Treatment Period plus up to 7 weeks follow-up])
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
- NCT number
- NCT04115293
- Phases
- PHASE3
- Conditions
- Myasthenia Gravis, Generalized
- Interventions
- zilucoplan (RA101495), Placebo
- Lead sponsor
- Ra Pharmaceuticals, Inc.
- Results first posted
- 2023-01-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04115293?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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