A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)

Model scores of the 29,894 trials active now.

Model score 8% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 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 2012-12-31. 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: safety tolerabilityallergicventricularsubjectsdouble blind
  Phrases that lowered it: blood pressurekghealthysingle dosethe pharmacokinetics
• Sponsor's past termination rate: 16.2% (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 317 (raises risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Disease area, cancer: Yes (raises risk) · Disease area
• Sponsor's past trials: 1104 (raises risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: basic science (lowers risk) · Design
• Drug's FAERS reports with a death: 13.6% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 94.5% (raises risk) · Drug's FDA history
• Disease area, psychiatry: No (lowers risk) · Disease area
• Number of arms: 3 (lowers risk) · Design
• Drug's FAERS reports in the prior 12 months: 1390 (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.

• A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06) NCT02015156 · started 2014 · scored riskier than 4% of active trials completed
• Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects NCT02075073 · started 2014 · scored riskier than 2% of active trials completed
• A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects NCT03776240 · started 2019 · scored riskier than 3% of active trials completed
• A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects NCT03242239 · started 2016 · scored riskier than 2% of active trials completed
• Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults NCT02100917 · started 2014 · scored riskier than 1% 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.