Comparison · NCT03131219-sae
Complement Inhibitor Treatment Naïve vs Eculizumab Experienced: 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. Complement Inhibitor Treatment Naïve vs Eculizumab Experienced: serious adverse events. Trial comparisons, record NCT03131219-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03131219-sae
On this page
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 | 0.667 | 0.467 | 0.82 | wilson | |
| Risk in group 2 | 0.1 | 0.0179 | 0.404 | wilson | |
| Risk difference, group 1 minus group 2 | 0.567 | 0.203 | 0.741 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 6.67 | 1.02 | 43.7 | log | |
| Odds ratio, group 1 over group 2 | 18 | 1.93 | 168 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Complement Inhibitor Treatment Naïve than on Eculizumab Experienced | 1.76 | 1.35 | 4.93 | 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 | Complement Inhibitor Treatment Naïve | Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab. | 16 | 24 | EG000 |
| Group 2 | Eculizumab Experienced | Eculizumab-experienced participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab. | 1 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the beginning of the initial evaluation period (Day 1) through data cutoff (at least 52 weeks and up to a maximum of 111 weeks of treatment, representing 36.2 patient-years of exposure).
Source ClinicalTrials.gov
Trial
- Title
- Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)
- NCT number
- NCT03131219
- Phases
- PHASE3
- Conditions
- Atypical Hemolytic Uremic Syndrome (aHUS)
- Interventions
- Ravulizumab
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2020-09-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03131219?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03131219-sae