Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL

Model scores of the 29,894 trials active now.

Model score 13% 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 2011-03-31. 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.

• 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
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: patientssymptomaticfunctionhave receivedmarrow
  Phrases that lowered it: singlerangemaleopenindex
• Drug's FAERS reports with a death: 37.5% (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports marked serious: 95.6% (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Minimum age: 4 (lowers risk) · Who can join
• Collaborators: 1 (raises risk) · Design
• Responsible party: sponsor (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.

• Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis NCT00628719 · started 2008 · scored riskier than 26% 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
• 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
• 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
• Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition NCT03636659 · started 2018 · scored riskier than 22% 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.