Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (40 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 2011-02-28. 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) (lowers risk) · Wording Phrases that raised it: patientprimaryassessplacebomri
  Phrases that lowered it: kneeosteoarthritisarticularjointpharmacokinetics
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Minimum age: 40 (lowers risk) · Who can join
• Responsible party: not given (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor's past termination rate: 12.7% (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 487 (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Maximum age: not given (lowers risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Blinding: double (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 182 (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.

• Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II NCT01598415 · started 2012 · scored riskier than 16% of active trials completed
• Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I NCT01463488 · started 2011 · scored riskier than 13% of active trials completed
• Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis NCT01511549 · started 2012 · scored riskier than 14% of active trials completed
• A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis NCT03133676 · started 2018 · scored riskier than 12% of active trials completed
• First-in-human Study With Ascending Single Intra-articular Doses of GZ389988 in Patients With Painful Osteoarthritis of the Knee NCT02424942 · started 2015 · scored riskier than 14% 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.