Comparison · NCT03748823-sae
Ravulizumab IV/SC Treatment Group vs Ravulizumab SC/SC Treatment Group: 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. Ravulizumab IV/SC Treatment Group vs Ravulizumab SC/SC Treatment Group: serious adverse events. Trial comparisons, record NCT03748823-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03748823-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 | 0.356 | 0.232 | 0.502 | wilson | |
| Risk in group 2 | 0.357 | 0.263 | 0.464 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00159 | -0.165 | 0.172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.996 | 0.612 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 0.993 | 0.466 | 2.12 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ravulizumab IV/SC Treatment Group than on Ravulizumab SC/SC Treatment Group | 630 | 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 | Ravulizumab IV/SC Treatment Group | During the Randomized Treatment Period, participants received a weight-based single loading dose (2400 to 2700 mg) of ravulizumab IV on Day 1, followed by a maintenance weight-based dose (3000 to 3300 mg) of ravulizumab IV on Day 15. During the Extension Period (Day 71 up to Day 1275), participants received 490 mg of ravulizumab SC qw. | 16 | 45 | EG000 |
| Group 2 | Ravulizumab SC/SC Treatment Group | During the Randomized Treatment Period, participants received a weight-based single loading dose (2400 to 2700 mg) of ravulizumab SC on Day 1, followed by maintenance weight-based doses (490 mg) of ravulizumab SC qw from Days 15 to 64. During the Extension Period (Day 71 up to Day 1275), participants received 490 mg of ravulizumab SC qw. | 30 | 84 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to approximately 3.5 years
Source ClinicalTrials.gov
Trial
- Title
- Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
- NCT number
- NCT03748823
- Phases
- PHASE3
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- Ravulizumab OBDS, Ravulizumab
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2022-10-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03748823?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/NCT03748823-sae