A Study of the Safety of REN001 in Patients With McArdle Disease

Model scores of the 29,894 trials active now.

Model score 18% 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 6% of the time (816 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 2021-10-11. 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: diabetesin subjectsthe subjectstableto assess
  Phrases that lowered it: screeningevaluate theto evaluatestudy todrug
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Number of arms: 1 (raises risk) · Design
• Responsible party: sponsor (lowers risk) · Design
• Maximum age: not given (lowers 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.

• A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy NCT03862846 · started 2019 · scored riskier than 27% of active trials terminated
• A Study to Evaluate the Safety of Aceneuramic Acid Extended Release (Ace-ER; UX001) Tablets in Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy (GNEM) (Also Known as Hereditary Inclusion Body Myopathy [HIBM]) Patients With Severe Ambulatory Impairment NCT02731690 · started 2016 · scored riskier than 32% of active trials terminated
• A Phase 1b Study of the Safety of REN001 in Patients With Fatty Acid Oxidation Disorders NCT03833128 · started 2019 · scored riskier than 16% of active trials completed
• An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead) NCT05267574 · started 2022 · scored riskier than 98% of active trials terminated
• An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients NCT04535609 · started 2021 · scored riskier than 87% 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.