Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

Model scores of the 29,894 trials active now.

Model score 14% 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 6% of the time (776 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 2017-12-28. 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
• Sponsor's past termination rate: 9.8% (raises risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: childrenbreastpositiveto assessassess the
  Phrases that lowered it: patients whoresistantfirst dosepharmacokineticsto visit
• Disease area, cancer: No (lowers risk) · Disease area
• Maximum age: 17 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 32 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 4 (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past trials: 92 (lowers risk) · Sponsor's track record
• Disease area, infectious disease: Yes (lowers risk) · Disease area
• Disease area, neurology: No (lowers risk) · Disease area
• Collaborators: 0 (raises 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.

• A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB) NCT01859923 · started 2013 · scored riskier than 35% of active trials completed
• Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV NCT03141060 · started 2019 · scored riskier than 48% of active trials completed
• Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis NCT01424670 · started 2011 · scored riskier than 15% of active trials completed
• Treatment Shortening of MDR-TB Using Existing and New Drugs NCT02619994 · started 2016 · scored riskier than 21% of active trials completed
• Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis NCT03086486 · started 2017 · scored riskier than 35% 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.