Comparison · NCT03512275-sae
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) vs Group B: Bermekimab 400 mg (Anti-TNF Naive): 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. Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) vs Group B: Bermekimab 400 mg (Anti-TNF Naive): serious adverse events. Trial comparisons, record NCT03512275-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03512275-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 | 0.0833 | 0.0232 | 0.258 | wilson | |
| Risk in group 2 | 0 | 0 | 0.176 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0833 | -0.103 | 0.258 | 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 harm, for one more participant with a serious adverse event on Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) than on Group B: Bermekimab 400 mg (Anti-TNF Naive) | 12 | 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 | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy. | 2 | 24 | EG000 |
| Group 2 | Group B: Bermekimab 400 mg (Anti-TNF Naive) | Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy. | 0 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Visit 14 (up to Day 93)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Bermekimab in Patients With Hidradenitis Suppurativa
- NCT number
- NCT03512275
- Phases
- PHASE2
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Bermekimab Monoclonal Antibody 400 mg
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2022-03-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03512275?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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