Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder

Model scores of the 29,894 trials active now.

Model score 18% 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 12% of the time (422 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 2020-01-03. 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: has historyivtolerabilitycurrentlycardiac
  Phrases that lowered it: conductedasthmavisitageddose
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 9.7% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports marked serious: 36.0% (lowers risk) · Drug's FDA history
• Drug's FAERS reports with a death: 2.0% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 22 (lowers risk) · Sponsor's track record
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 4 (lowers risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Maximum age: 5 (lowers risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area

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.

• Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD) NCT03260205 · started 2017 · scored riskier than 51% of active trials completed
• Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder NCT02402166 · started 2015 · scored riskier than 62% of active trials completed
• Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) NCT01244490 · started 2011 · scored riskier than 12% of active trials completed
• Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe NCT01500694 · started 2012 · scored riskier than 13% of active trials completed
• Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD) NCT01081145 · started 2010 · scored riskier than 11% 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.