A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies

Model scores of the 29,894 trials active now.

Model score 25% 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 15% of the time (734 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 2023-08-21. 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: long termkeyterm safetyextensionthe long
  Phrases that lowered it: participantevaluateindexcould interfereefficacy
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 16.9% (raises risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Phase: 3 (lowers 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
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 53 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor's past trials: 183 (lowers risk) · Sponsor's track record
• Number of arms: 5 (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Minimum age: not given (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• 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.

• An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246) NCT02052791 · started 2014 · scored riskier than 39% of active trials completed
• An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1 (NCT01494701) NCT01780246 · started 2013 · scored riskier than 66% of active trials completed
• A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA) NCT02292537 · started 2014 · scored riskier than 95% of active trials completed
• An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy NCT01703988 · started 2012 · scored riskier than 91% of active trials completed
• An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) NCT01494701 · started 2011 · scored riskier than 81% 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.