Comparison · NCT05339087-sae
Riociguat 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. Riociguat vs Placebo: serious adverse events. Trial comparisons, record NCT05339087-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05339087-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 | 0.118 | 0.0329 | 0.343 | wilson | |
| Risk in group 2 | 0.0556 | 0.00988 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0621 | -0.157 | 0.292 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.12 | 0.211 | 21.3 | log | |
| Odds ratio, group 1 over group 2 | 2.27 | 0.186 | 27.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Riociguat than on Placebo | 16.1 | 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 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | 2 | 17 | EG000 |
| Group 2 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. | 1 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug). With a treatment phase of 24 weeks (± 14 days), the overall adverse event data collection period corresponds to approximately 28 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH
- NCT number
- NCT05339087
- Phases
- PHASE2
- Conditions
- Pulmonary Vascular Disorder, Primary Pulmonary Hypertension, Systemic Sclerosis, Other Systemic Involvement of Connective Tissue
- Interventions
- Riociguat Oral Tablet, Placebo
- Lead sponsor
- Heidelberg University
- Results first posted
- 2026-01-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05339087?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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