Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia

Model scores of the 29,894 trials active now.

Model score 24% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 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 2023-11-17. 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: cancercellcarcinomapriortherapy
  Phrases that lowered it: subjectsat screeningto evaluateefficacysafety
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Phase: 2 (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 3 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 90 (lowers risk) · Who can join
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Collaborators: 0 (raises 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.

• Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia NCT02144610 · started 2014 · scored riskier than 91% of active trials terminated
• An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI) NCT01483898 · started 2012 · scored riskier than 76% of active trials completed
• A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia NCT02016755 · started 2013 · scored riskier than 96% of active trials completed
• The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM NCT03174522 · started 2017 · scored riskier than 82% of active trials terminated
• Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization NCT03006770 · started 2017 · scored riskier than 66% 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.