Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates

Model scores of the 29,894 trials active now.

Model score 11% 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 23% of the time (60 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 2010-12-31. 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.

• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: termdoseintravenouspainadministration of
  Phrases that lowered it: safety ofpharmacokineticsand safetyevaluatemultiple
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: single group (raises risk) · Design
• Phase: 2/3 (raises risk) · Design
• Responsible party: not given (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: 16.9% (lowers risk) · Drug's FDA history
• Minimum age: not given (raises risk) · Who can join
• Maximum age: 0.08 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Sponsor's past trials: 12 (lowers risk) · Sponsor's track record
• Drug's FAERS reports in the prior 12 months: 7131 (lowers risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 13 (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.

• The Preterm Infants' Paracetamol Study NCT01938261 · started 2013 · scored riskier than 12% of active trials completed
• Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus NCT04037514 · started 2017 · scored riskier than 19% of active trials completed
• Extremely Low Gestatonal Age Infants' Paracetamol Study NCT03641209 · started 2018 · scored riskier than 29% of active trials completed
• A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients NCT01635101 · started 2012 · scored riskier than 42% of active trials completed
• Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® NCT01540734 · started 2009 · 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.