Comparison · NCT02138825-d97dc2c7
Riociguat up to 2.5 mg Tid vs Placebo: Number of Serious Adverse Events During Safety Follow-up Phase
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 up to 2.5 mg Tid vs Placebo: Number of Serious Adverse Events During Safety Follow-up Phase. Trial comparisons, record NCT02138825-d97dc2c7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02138825-d97dc2c7
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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 | 0.247 | 0.162 | 0.356 | wilson | |
| Risk in group 2 | 0.189 | 0.116 | 0.293 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0574 | -0.0764 | 0.189 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.702 | 2.42 | log | |
| Odds ratio, group 1 over group 2 | 1.4 | 0.638 | 3.09 | log | |
| Number needed to treat, for one more participant with the outcome on Riociguat up to 2.5 mg Tid than on Placebo | 17.4 | 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 up to 2.5 mg Tid | All participants that were initially randomized to Rioiciguat treatment were taken off study drug at the time of study termination, and started the 120 days safety follow-up phase, regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days. | 18 | 73 | OG000 |
| Group 2 | Placebo | All participants that were initially randomized to placebo were taken off study drug at the time of study termination, and started the 120 days safety follow-up phase, regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days. | 14 | 74 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- POST_HOC
- Title
- Number of Serious Adverse Events During Safety Follow-up Phase
- Description
At the time of study termination, all participants entered safety follow-up phase regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.
- Time frame
- From start of safety follow-up phase until end of study
- Population
- Safety analysis set: participants randomized and received at least one dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)
- NCT number
- NCT02138825
- Phases
- PHASE2
- Conditions
- Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
- Interventions
- Riociguat (Adempas, BAY63-2521), Placebo
- Lead sponsor
- Bayer
- Results first posted
- 2017-06-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02138825?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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