Comparison · NCT04722991-sae
Runcaciguat (BAY1101042) 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. Runcaciguat (BAY1101042) vs Placebo: serious adverse events. Trial comparisons, record NCT04722991-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04722991-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 | 0.161 | 0.0869 | 0.278 | wilson | |
| Risk in group 2 | 0.0566 | 0.0194 | 0.154 | wilson | |
| Risk difference, group 1 minus group 2 | 0.104 | -0.0178 | 0.227 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.84 | 0.812 | 9.92 | log | |
| Odds ratio, group 1 over group 2 | 3.19 | 0.814 | 12.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Runcaciguat (BAY1101042) than on Placebo | 9.61 | 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 | Runcaciguat (BAY1101042) | Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps. | 9 | 56 | EG000 |
| Group 2 | Placebo | Participants received matching placebo GITS tablets. | 3 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
After the first study intervention up to 28 days after the end of study intervention, with an average up to 53 weeks. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of/ up to 54 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
- NCT number
- NCT04722991
- Phases
- PHASE2
- Conditions
- Diabetic Retinopathy
- Interventions
- Runcaciguat (BAY1101042), Placebo
- Lead sponsor
- Bayer
- Results first posted
- 2025-04-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04722991?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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