Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy

Model scores of the 29,894 trials active now.

Model score 16% 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 14% of the time (493 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 2010-11-30. 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: breastiicancerlifeenrollment
  Phrases that lowered it: plasmasubjectsassess theto assessthe study
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: not given (raises risk) · Who can join
• Number of arms: 2 (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.

• An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure NCT00803101 · started 2009 · scored riskier than 54% of active trials completed
• Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects NCT02281201 · started 2014 · scored riskier than 19% of active trials completed
• Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. NCT02740335 · started 2017 · scored riskier than 85% of active trials completed
• Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor NCT04867837 · started 2021 · scored riskier than 47% of active trials terminated
• A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study) NCT02329327 · started 2015 · scored riskier than 76% 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.