Comparison · NCT04557735-sae
Treatment Period: Ravulizumab vs Follow-up Period: Ravulizumab: 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. Treatment Period: Ravulizumab vs Follow-up Period: Ravulizumab: serious adverse events. Trial comparisons, record NCT04557735-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04557735-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 | 0.732 | 0.581 | 0.843 | wilson | |
| Risk in group 2 | 0.517 | 0.344 | 0.686 | wilson | |
| Risk difference, group 1 minus group 2 | 0.214 | -0.0121 | 0.42 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.41 | 0.951 | 2.11 | log | |
| Odds ratio, group 1 over group 2 | 2.55 | 0.933 | 6.95 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Treatment Period: Ravulizumab than on Follow-up Period: Ravulizumab | 4.66 | 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 | Treatment Period: Ravulizumab | Participants received weight-based dosages of ravulizumab intravenously for 26 weeks during the Treatment Period. Participants received a loading dose of ravulizumab intravenously on Days 1, 5 and 10 followed by maintenance dosing on Day 15 and once every 8 weeks or every 4 weeks thereafter depending upon their body weight. | 30 | 41 | EG000 |
| Group 2 | Follow-up Period: Ravulizumab | After the completion of the treatment period, participants were followed for 26 Weeks in Follow-up period (no study drug was administered during this period). | 15 | 29 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to Week 52
Source ClinicalTrials.gov
Trial
- Title
- Study of Ravulizumab in Pediatric Participants With HSCT-TMA
- NCT number
- NCT04557735
- Phases
- PHASE3
- Conditions
- Thrombotic Microangiopathy
- Interventions
- Ravulizumab, Best Supportive Care
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2026-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04557735?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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