Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers

Model scores of the 29,894 trials active now.

Model score 3% 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 6% of the time (355 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 2009-06-30. 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) (lowers risk) · Wording Phrases that raised it: lowarterystudy ofriskarterial
  Phrases that lowered it: volunteershealthyinhalationsafetytolerability
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Drug's FAERS reports marked serious: 60% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Number of arms: 5 (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports with a death: 12% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 55 (lowers risk) · Who can join
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 0 (lowers risk) · Sponsor's track record
• Disease area, psychiatry: No (lowers risk) · Disease area

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.

• Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects NCT01409122 · started 2011 · scored riskier than 3% of active trials completed
• Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects NCT00920933 · started 2009 · scored riskier than 6% of active trials completed
• Inhaled Nitrite in Subjects With Pulmonary Hypertension NCT01431313 · started 2012 · scored riskier than 63% of active trials completed
• Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers. NCT06662019 · started 2024 · scored riskier than 3% of active trials completed
• Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair NCT00927758 · started 2009 · scored riskier than 11% 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.