Comparison · NCT04156620-sae
Any AIN457 vs Placebo Until 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. Any AIN457 vs Placebo Until Week 16: serious adverse events. Trial comparisons, record NCT04156620-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04156620-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 | 0.0619 | 0.0442 | 0.0861 | wilson | |
| Risk in group 2 | 0.0115 | 0.00392 | 0.0332 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0504 | 0.0224 | 0.0757 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5.38 | 1.66 | 17.4 | log | |
| Odds ratio, group 1 over group 2 | 5.67 | 1.72 | 18.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Any AIN457 than on Placebo Until Week 16 | 19.8 | 13.2 | 44.7 | 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 | Any AIN457 | Participants received secukinumab (AIN457) 6 mg/kg i.v. at baseline, followed by secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52); placebo participants who switched at Week 16 received secukinumab 3 mg/kg i.v. every four weeks starting at Week 16 through Week 48 (exposure through Week 52) | 32 | 517 | EG000 |
| Group 2 | Placebo Until Week 16 | Participants received i.v. placebo at baseline visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52 | 3 | 261 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up.
Source ClinicalTrials.gov
Trial
- Title
- Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
- NCT number
- NCT04156620
- Phases
- PHASE3
- Conditions
- Ankylosing Spondylitis
- Interventions
- Secukinumab, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2024-01-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04156620?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/NCT04156620-sae