Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 3% 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 2015-09-30. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: chronic kidneykidney diseaseheartevidence30
  Phrases that lowered it: patientsterm safetyopen labeldrugslong term
• Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past trials: 315 (lowers risk) · Sponsor's track record
• Drug's FAERS reports in the prior 12 months: 30547 (lowers risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 74.6% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 277 (raises risk) · Sponsor's track record
• Drug's FAERS reports before start: 133512 (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 6 (raises risk) · Who can join
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Collaborators: 0 (raises risk) · Design
• Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
• Blinding: none (lowers risk) · Design

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.

• Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD NCT01617681 · started 2012 · scored riskier than 77% of active trials completed
• Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients NCT01447485 · started 2011 · scored riskier than 9% of active trials completed
• Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis NCT02341417 · started 2015 · scored riskier than 61% of active trials completed
• Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF NCT03785405 · started 2019 · scored riskier than 57% of active trials completed
• A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults NCT01078376 · started 2010 · scored riskier than 4% 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.