Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 1% 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 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 2013-09-17. 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: No (raises risk) · Who can join
• Sponsor's past termination rate: 4.1% (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 35.9% (lowers risk) · Drug's FDA history
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: placebodiagnosisrandomizationbipolartreatment
  Phrases that lowered it: participantsand safetyefficacy andsafety ofparticipant
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 2.2% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
• Number of arms: 4 (lowers risk) · Design
• Sponsor's past trials: 362 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 10 (raises risk) · Who can join
• Maximum age: 17 (raises risk) · Who can join
• Collaborators: 0 (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.

• Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) NCT00764478 · started 2012 · scored riskier than 13% of active trials completed
• Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898) NCT01349907 · started 2011 · scored riskier than 16% of active trials completed
• Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384) NCT01396291 · started 2011 · scored riskier than 9% of active trials completed
• Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients NCT01567527 · started 2012 · scored riskier than 36% of active trials completed
• A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode NCT00606281 · started 2008 · scored riskier than 17% 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.