Comparison · NCT02891850-sae
Riociguat vs PDE-5i: 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. Riociguat vs PDE-5i: serious adverse events. Trial comparisons, record NCT02891850-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02891850-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 | 0.0721 | 0.037 | 0.136 | wilson | |
| Risk in group 2 | 0.167 | 0.109 | 0.246 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0946 | -0.181 | -0.0089 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.432 | 0.198 | 0.947 | log | |
| Odds ratio, group 1 over group 2 | 0.388 | 0.162 | 0.929 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Riociguat than on PDE-5i | 10.6 | 5.52 | 112 | from the risk difference interval |
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 | Riociguat | Participants received BAY63-2521 tablets at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg three times a day (TID) for 24 weeks, started with 1.0 mg TID, followed by a dose adjustment period of 8 weeks, then stayed at the optimal dose period of 16 weeks. | 8 | 111 | EG000 |
| Group 2 | PDE-5i | Participants remained on their current pulmonary arterial hypertension (PAH) treatment on tadalafil (20 to 40 mg/day) or sildenafil (at least 60 mg/day) for 24 weeks at the discretion of the investigator. | 19 | 114 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The adverse events were considered to be treatment emergent if they had started or worsened after the first treatment administration and up to 2 days after end of treatment. Since maximum study duration was 24 weeks, this could be up to 24 weeks + 2 days.
Source ClinicalTrials.gov
Trial
- Title
- Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
- NCT number
- NCT02891850
- Phases
- PHASE4
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Riociguat (Adempas, BAY63-2521), Sildenafil, Tadalafil
- Lead sponsor
- Bayer
- Results first posted
- 2021-01-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02891850?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/NCT02891850-sae