A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04

Model scores of the 29,894 trials active now.

Model score 5% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 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 2015-01-31. 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: enrollmentbiopsyplacebochronicdisease
  Phrases that lowered it: tenofovirtrialsafety ofparticipantsvisit
• Primary purpose: not given (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Collaborators: 2 (lowers risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 18.4% (lowers risk) · Drug's FDA history
• Number of arms: 5 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past trials: 13 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 95.3% (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 7 (lowers risk) · Sponsor's track record
• Responsible party: principal investigator (lowers risk) · Design
• Drug's FAERS reports before start: 1916 (raises 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.

• PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel NCT03467347 · started 2018 · scored riskier than 2% of active trials completed
• Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission of HSV and HIV NCT02579083 · started 2016 · scored riskier than 4% of active trials completed
• Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert NCT06087913 · started 2023 · scored riskier than 4% of active trials completed
• Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women NCT02010593 · started 2013 · scored riskier than 7% of active trials completed
• Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring (TDF IVR-002) NCT02762617 · started 2017 · scored riskier than 6% 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.