Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 5% 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 (1,304 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 2014-03-07. 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: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: concurrentto determinediarrheaassociatedbowel
  Phrases that lowered it: pharmacokineticssafety tolerabilitythe safetytolerability andsubjects
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: single group (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: 33.3% (raises risk) · Drug's FDA history
• Maximum age: 18 (raises risk) · Who can join
• Blinding: none (raises risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 4 (raises risk) · Sponsor's track record
• Number of arms: 1 (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Drug's FAERS reports before start: 27 (lowers risk) · Drug's FDA history
• Sponsor type: industry (lowers 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.

• A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) NCT02218372 · started 2015 · scored riskier than 18% of active trials completed
• Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) NCT01691248 · started 2012 · scored riskier than 31% of active trials completed
• Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection NCT02395848 · started 2015 · scored riskier than 46% of active trials terminated
• Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections NCT01232595 · started 2010 · scored riskier than 39% of active trials completed
• Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea NCT01987895 · started 2014 · scored riskier than 18% 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.