Long-term Safety Extension to Study TRCA-301

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 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 2019-02-22. 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: subjectsextensionterm safetythe longlong term
  Phrases that lowered it: effect ofbloodevaluate theto evaluategastrointestinal
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• 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
• Blinding: triple (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 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.

• Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease NCT03317444 · started 2017 · scored riskier than 27% of active trials completed
• Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis NCT03710291 · started 2018 · scored riskier than 45% of active trials terminated
• Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis NCT02809183 · started 2016 · scored riskier than 11% of active trials completed
• Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis NCT01785875 · started 2013 · scored riskier than 90% of active trials completed
• Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis NCT02102204 · started 2014 · scored riskier than 47% 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.