Comparison · NCT02915835-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
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ConductScience Library. Riociguat vs Placebo: serious adverse events. Trial comparisons, record NCT02915835-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02915835-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 | 0.333 | 0.121 | 0.646 | wilson | |
| Risk in group 2 | 0.125 | 0.0224 | 0.471 | wilson | |
| Risk difference, group 1 minus group 2 | 0.208 | -0.198 | 0.537 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.67 | 0.342 | 20.8 | log | |
| Odds ratio, group 1 over group 2 | 3.5 | 0.284 | 43.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Riociguat than on Placebo | 4.8 | 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 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)~Riociguat: riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered) | 3 | 9 | EG000 |
| Group 2 | Placebo | Matching placebo tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg matching placebo tablet.~Placebo: Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; | 1 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 16 weeks
Source ClinicalTrials.gov
Trial
- Title
- Riociguat in Scleroderma Associated Digital Ulcers
- NCT number
- NCT02915835
- Phases
- PHASE2
- Conditions
- Scleroderma, Digital Ulcers
- Interventions
- Riociguat, Placebo
- Lead sponsor
- Dinesh Khanna, MD, MS
- Results first posted
- 2019-09-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02915835?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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