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

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 4% 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 2025-09-02. 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: placeboconstipationbowelcancerextension
  Phrases that lowered it: participantparticipantsopen labelthe effecteffect of
• Sponsor's past termination rate: 15.7% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports marked serious: 32.8% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 3.4% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 84 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 2 (lowers risk) · Who can join
• Number of arms: 3 (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.

• 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
• 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
• A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC) NCT02559570 · started 2015 · scored riskier than 22% 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 Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation NCT02559817 · started 2015 · scored riskier than 25% 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.