Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

Model scores of the 29,894 trials active now.

Model score 18% 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 21% of the time (63 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 2014-09-30. 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: 13.9% (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 276 (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: long termtolerabilityhoursterm safetystudy of
  Phrases that lowered it: efficacy andand safetyopen labelpatients wholabel study
• 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
• Sponsor's past trials: 337 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Phase: 2/3 (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 18 (raises risk) · Who can join
• Collaborators: 0 (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Keywords listed: 5 (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.

• Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome NCT01348087 · started 2011 · scored riskier than 83% of active trials terminated
• Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome NCT01357239 · started 2011 · scored riskier than 85% of active trials completed
• Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients NCT00718341 · started 2008 · scored riskier than 11% of active trials completed
• Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS) NCT01482143 · started 2012 · scored riskier than 13% of active trials completed
• An Open Label Extension Study in Subjects With Fragile X Syndrome NCT01555333 · started 2011 · scored riskier than 84% 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.