Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization

Model scores of the 29,894 trials active now.

Model score 7% 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 2014-01-31. 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: placeboheartqthourscoronary
  Phrases that lowered it: healthyinvestigatorsinglerangethe effect
• Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, cancer: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 15.5% (lowers risk) · Drug's FDA history
• Sponsor's past trials: 12 (lowers risk) · Sponsor's track record
• Sex: male (lowers risk) · Who can join
• Drug's FAERS reports in the prior 12 months: 469 (raises risk) · Drug's FDA history
• Drug's FAERS reports before start: 2395 (raises risk) · Drug's FDA history
• Blinding: quadruple (lowers 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.

• This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers. NCT01702376 · started 2012 · scored riskier than 3% of active trials completed
• Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects NCT01873950 · started 2013 · scored riskier than 2% of active trials completed
• This Study Will Investigate the Safety, Tolerability and Pharmacokinetic Profile of Repeat Oral Doses of GSK2140944 in Healthy Adult Subjects NCT01706315 · started 2012 · scored riskier than 21% of active trials completed
• To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects NCT01449188 · started 2011 · scored riskier than 5% of active trials completed
• Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat and Its Major Metabolites on the Heart NCT05933447 · started 2023 · scored riskier than 4% 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.