Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer

Model scores of the 29,894 trials active now.

Model score 15% 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 16% of the time (1,938 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-08-16. 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.

• Sponsor's past termination rate: 43.2% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancerstagechemotherapycarcinomamyeloid
  Phrases that lowered it: breast cancerproductsevaluatedrugbetween 18
• Phase: 1 (lowers risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Disease area, cancer: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: 17.6% (lowers risk) · Drug's FDA history
• Number of arms: 4 (lowers risk) · Design
• Design: sequential (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports before start: 166937 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 29740 (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
• Maximum age: 55 (lowers risk) · Who can join
• Drug's FAERS reports marked serious: 87.7% (lowers 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.

• SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide NCT02953340 · started 2017 · scored riskier than 56% of active trials completed
• Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy NCT03135951 · started 2017 · scored riskier than 72% of active trials completed
• SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) NCT02643420 · started 2016 · scored riskier than 60% of active trials completed
• Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients NCT02104830 · started 2013 · scored riskier than 30% of active trials completed
• Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer NCT01724866 · started 2013 · scored riskier than 60% 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.