Comparison · NCT04124965-sae
Rozanolixizumab ~7 mg/kg vs Rozanolixizumab ~10 mg/kg: 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. Rozanolixizumab ~7 mg/kg vs Rozanolixizumab ~10 mg/kg: serious adverse events. Trial comparisons, record NCT04124965-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04124965-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 | 0.14 | 0.0695 | 0.262 | wilson | |
| Risk in group 2 | 0.0476 | 0.0132 | 0.158 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0924 | -0.0385 | 0.219 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.94 | 0.645 | 13.4 | log | |
| Odds ratio, group 1 over group 2 | 3.26 | 0.638 | 16.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rozanolixizumab ~7 mg/kg than on Rozanolixizumab ~10 mg/kg | 10.8 | 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 | Rozanolixizumab ~7 mg/kg | Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). | 7 | 50 | EG000 |
| Group 2 | Rozanolixizumab ~10 mg/kg | Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). | 2 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline until End of Study (up to Week 60)
Source ClinicalTrials.gov
Trial
- Title
- A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
- NCT number
- NCT04124965
- Phases
- PHASE3
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- Rozanolixizumab
- Lead sponsor
- UCB Biopharma SRL
- Results first posted
- 2023-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04124965?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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