Comparison · NCT03123120-faf71708
Spesolimab 1200 mg - Actual vs Placebo - Actual: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Spesolimab 1200 mg - Actual vs Placebo - Actual: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT03123120-faf71708. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03123120-faf71708
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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 | 1 | 0.796 | 1 | wilson | |
| Risk in group 2 | 0.857 | 0.487 | 0.974 | wilson | |
| Risk difference, group 1 minus group 2 | 0.143 | -0.0923 | 0.513 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.862 | 1.58 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Spesolimab 1200 mg - Actual than on Placebo - Actual | 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 | Spesolimab 1200 mg - Actual | 1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment.~Participants who actually administered Spesolimab during the study were included in this group. 1 patient who was assigned to Placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group. | 15 | 15 | OG001 |
| Group 2 | Placebo - Actual | Matching placebo were administered via intravenous over 12 weeks of treatment. Participants who actually administered placebo during the study were included in this group. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group. | 6 | 7 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
- Number of participants with any treatment-emergent adverse events (TEAEs) was reported.
- Time frame
- From first does of study medication until end of the follow-up period, up to 36 weeks.
- Population
Safety Analysis Set (SAF): this patient set included all randomized patients who received at least one dose of trial drug. Treatment assignment was analyzed according to the actual treatment. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group in the SAF.
Source ClinicalTrials.gov
Trial
- Title
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
- NCT number
- NCT03123120
- Phases
- PHASE2
- Conditions
- Colitis, Ulcerative
- Interventions
- Spesolimab, Placebo
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2021-10-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03123120?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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