Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 16% of the time (370 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.
How it ended
Completed on 2014-01-31, after 2012-04-05 start.
The score above never used this outcome: 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.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-01-31. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: coronarysubjects within subjectscardiacrandomization
Phrases that lowered it: safety tolerabilityefficacyevaluatemgstudy to -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 5.7% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 86 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 245 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Maximum age: 80 (lowers risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Phase: 2/3 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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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.
The trial
Design
- Phase
- 2/3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 12 (typical: 18)
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 245 (typical: 32)
- Sponsor's past termination rate
- 5.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 86 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- evolocumab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study NCT01375751 · started 2011 · scored riskier than 27% of active trials completed
- Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2 NCT01763918 · started 2013 · scored riskier than 15% of active trials completed
- Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders NCT01624142 · started 2012 · scored riskier than 33% of active trials completed
- Study to Evaluate the Effects of MBX-8025 in Patients With HoFH NCT02472535 · started 2015 · scored riskier than 87% of active trials completed
- Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies. NCT05425745 · started 2022 · scored riskier than 45% 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.