Comparison · NCT04209205-sae
AIN457 6 mg/kg - 3 mg/kg i.v vs Placebo up to Week 16: 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. AIN457 6 mg/kg - 3 mg/kg i.v vs Placebo up to Week 16: serious adverse events. Trial comparisons, record NCT04209205-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04209205-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 | 0.0588 | 0.0392 | 0.0875 | wilson | |
| Risk in group 2 | 0.0211 | 0.00822 | 0.0529 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0378 | 0.000368 | 0.0691 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.79 | 0.977 | 7.99 | log | |
| Odds ratio, group 1 over group 2 | 2.91 | 0.987 | 8.56 | log | |
| Number needed to harm, for one more participant with a serious adverse event on AIN457 6 mg/kg - 3 mg/kg i.v than on Placebo up to Week 16 | 26.5 | 14.5 | 2,720 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AIN457 6 mg/kg - 3 mg/kg i.v | AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52). Includes participants switched from placebo at Week 16. | 22 | 374 | EG000 |
| Group 2 | Placebo up to Week 16 | Matching placebo from baseline to Week 16 | 4 | 190 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported from first dose of study treatment up to a maximum of 481 days which included an approximate follow up period of 8 weeks for AIN457 treatment group.
Source ClinicalTrials.gov
Trial
- Title
- Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
- NCT number
- NCT04209205
- Phases
- PHASE3
- Conditions
- Psoriatic Arthritis
- Interventions
- AIN457 6 mg/kg i.v., Placebo, AIN457 3 mg/kg
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2024-04-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04209205?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/NCT04209205-sae