A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2012-05-14. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: pulmonaryplacebo controlledhypertensionarterialblind placebo
  Phrases that lowered it: patientsand safetysafety ofefficacy andthe efficacy
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor's past termination rate: 4.7% (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 103 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Number of arms: 3 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Maximum age: 80 (raises risk) · Who can join
• Disease area, respiratory: Yes (raises risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
• Sponsor's past trials: 234 (lowers risk) · Sponsor's track record

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.

• A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. NCT00855465 · started 2009 · scored riskier than 16% of active trials completed
• Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID NCT00680654 · started 2008 · scored riskier than 45% of active trials completed
• BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension NCT00863681 · started 2009 · scored riskier than 25% of active trials completed
• This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT03754660 · started 2019 · scored riskier than 28% of active trials completed
• Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study NCT01469169 · started 2012 · scored riskier than 20% of active trials completed

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.