A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)

Model scores of the 29,894 trials active now.

Model score 33% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 16% of the time (370 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-07-02. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: placeboheartventricularleftextension
  Phrases that lowered it: lungparticipantsand safetypulmonarymk
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 17.1% (raises risk) · Sponsor's track record
• Sponsor's past trials: 1325 (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 121 (lowers risk) · Sponsor's track record
• Number of arms: 6 (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Disease area, respiratory: Yes (raises risk) · Disease area
• Collaborators: 0 (raises risk) · Design
• Maximum age: 75 (raises risk) · Who can join

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.

• Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003) NCT01934647 · started 2013 · scored riskier than 48% of active trials terminated
• 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
• Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters. NCT01179334 · started 2010 · scored riskier than 20% of active trials completed
• A Study of Single Doses of Frespaciguat (MK-5475) on Pulmonary Vascular Resistance (MK-5475-002) NCT03744637 · started 2019 · scored riskier than 59% of active trials completed
• Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH NCT05339087 · started 2022 · scored riskier than 68% 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.