Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

Model scores of the 29,894 trials active now.

Model score 33% 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 14% of the time (493 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 2021-11-12. 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: the subjectin subjectstolerabilitysubjects withfailure
  Phrases that lowered it: open labelevaluate theto evaluateinvestigate theto investigate
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 3.6% (lowers risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Minimum age: 30 (lowers risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 10 (raises risk) · Sponsor's track record
• Sponsor's past trials: 28 (lowers risk) · Sponsor's track record
• Number of arms: 1 (raises risk) · Design
• Keywords listed: 20 (raises risk) · Design
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history

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.

• TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) NCT02705755 · started 2017 · scored riskier than 15% of active trials completed
• Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure NCT03750552 · started 2019 · scored riskier than 70% of active trials completed
• Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) NCT00738062 · started 2008 · scored riskier than 24% of active trials completed
• A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa NCT00782340 · started 2008 · scored riskier than 48% of active trials completed
• Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure NCT03829657 · started 2019 · scored riskier than 77% of active trials terminated

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.