Comparison · NCT04181762-sae
Secukinumab 300 mg 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. Secukinumab 300 mg vs Placebo: serious adverse events. Trial comparisons, record NCT04181762-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04181762-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 | 0.219 | 0.158 | 0.295 | wilson | |
| Risk in group 2 | 0.283 | 0.214 | 0.363 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0636 | -0.164 | 0.0389 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.775 | 0.513 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.712 | 0.411 | 1.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Secukinumab 300 mg than on Placebo | 15.7 | 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 | Secukinumab 300 mg | A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 786 days). | 30 | 137 | EG000 |
| Group 2 | Placebo | A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 794 days). | 39 | 138 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- On-treatment adverse events and deaths were reported from first dose of study treatment to 84 days after last dose of study medication, assessed up to approximately 2 years.
Source ClinicalTrials.gov
Trial
- Title
- Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
- NCT number
- NCT04181762
- Phases
- PHASE3
- Conditions
- Lupus Nephritis
- Interventions
- secukinumab, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2024-10-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04181762?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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