Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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 2025-06-05. 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: 13.6% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: anemiapainan investigationalironloss
  Phrases that lowered it: participantopen labelparticipantsvisitphase open
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 87 (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• 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
• Maximum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 177 (lowers risk) · Sponsor's track record
• Number of arms: 3 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Collaborators: 1 (raises risk) · Design
• Blinding: none (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area

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.

• Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation NCT04110145 · started 2019 · scored riskier than 72% of active trials completed
• Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) NCT04026113 · started 2019 · scored riskier than 57% of active trials completed
• A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation NCT05652205 · started 2022 · scored riskier than 49% of active trials completed
• A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide NCT05760313 · started 2023 · scored riskier than 65% of active trials completed
• A Study of Prucalopride For Functional Constipation in Children and Teenagers NCT04759833 · started 2021 · scored riskier than 38% 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.