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

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 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 2011-06-30. 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) (raises risk) · Wording Phrases that raised it: patientsbonemarrowiinode
  Phrases that lowered it: singlebmiinclusiveclinical trialaged
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 14.6% (lowers risk) · Drug's FDA history
• Collaborators: 2 (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 70.1% (lowers risk) · Drug's FDA history
• Number of arms: 3 (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Blinding: none (raises risk) · Design
• Maximum age: 60 (lowers risk) · Who can join
• Drugs with FDA adverse-event history: 5 (lowers risk) · Drug's FDA history
• Sponsor's past trials: 4 (raises risk) · Sponsor's track record

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
• Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients. NCT02011958 · started 2014 · scored riskier than 64% of active trials completed
• 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
• 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

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.