Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 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 2016-09-30. 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
• Sponsor's past termination rate: 13.3% (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: assess30 kgprotocolpatientssevere
  Phrases that lowered it: trialcombinationand safetysafety ofefficacy and
• Design: single group (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Minimum age: 4 (lowers risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Maximum age: 12 (raises risk) · Who can join
• Number of arms: 1 (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports with a death: 20% (lowers risk) · Drug's FDA history
• Sponsor's past trials: 15 (lowers risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Drug's FAERS reports before start: 35 (lowers 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.

• Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa NCT03129646 · started 2018 · scored riskier than 17% of active trials completed
• Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa NCT01067443 · started 2010 · scored riskier than 40% of active trials completed
• Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL NCT00832208 · started 2009 · scored riskier than 27% of active trials terminated
• Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis NCT00696969 · started 2008 · scored riskier than 44% of active trials completed
• Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh NCT01122771 · started 2010 · scored riskier than 42% 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.