Comparison · NCT04762277-sae
Spesolimab 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. Spesolimab vs Placebo: serious adverse events. Trial comparisons, record NCT04762277-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04762277-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 | 0 | 0.0964 | wilson | |
| Risk in group 2 | 0.0625 | 0.0111 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0625 | -0.283 | 0.0468 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Spesolimab than on Placebo | 16 | 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 | Spesolimab | Patients received 1200 mg of spesolimab administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10. | 0 | 36 | EG001 |
| Group 2 | Placebo | Patients received placebo administered intravenously (i.v.) at Weeks 0, 1, and 2, and subcutaneously injection at Weeks 4, 6, 8, and 10. | 1 | 16 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From first drug administration until 16 weeks after last drug administration, up to 28 weeks for patients who did not to roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)). From first drug administration until Week 12 for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
- NCT number
- NCT04762277
- Phases
- PHASE2
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Spesolimab - solution for infusion, Placebo matching spesolimab - solution for infusion, Spesolimab- solution for injection, Placebo matching to spesolimab- solution for injection
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2024-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04762277?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/NCT04762277-sae