Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 15% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-07-31, after 2022-10-24 start.
Reason given by the sponsor: “business”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-07-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: screeningplacebo controlled30double blindmass
Phrases that lowered it: patientsmklungaccordingfev1 -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10.1% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: double (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Responsible party: principal investigator (lowers risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 78.7% (lowers risk) · Drug's FDA history
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 22.0% (raises risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 109 (typical: 32)
- Sponsor's past termination rate
- 10.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 22615 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2912 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory, dermatology
- Drugs matched to FDA substances
- riociguat
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) NCT00989963 · started 2010 · scored riskier than 82% of active trials completed
- Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy NCT01560624 · started 2012 · scored riskier than 94% of active trials completed
- Beraprost-314d Added-on to Tyvaso® (BEAT) NCT01908699 · started 2013 · scored riskier than 90% of active trials completed
- Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction NCT02744339 · started 2016 · scored riskier than 70% of active trials completed
- Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP) NCT02138825 · started 2014 · scored riskier than 54% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.