Effect of Evolocumab on Coronary Atherosclerosis
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-05-30, after 2019-03-19 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2023-05-30. 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: coronaryarteryanginacardiacplaque
Phrases that lowered it: effect ofevaluatelabelallergyhistory -
Sponsor's past termination rate: 25.2% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 61.6% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 9.2% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 46 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 302231 (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 62344 (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 103 (typical: 32)
- Sponsor's past termination rate
- 25.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 46 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 302231 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 62344 (typical: 412.5)
- Drug's FAERS reports marked serious
- 61.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, metabolic
- Drugs matched to FDA substances
- evolocumab, iohexol, metoprolol, nitroglycerin
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
- GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound NCT01813422 · started 2013 · scored riskier than 79% of active trials completed
- Imaging of Coronary Plaques in Participants Treated With Evolocumab NCT03570697 · started 2018 · scored riskier than 69% of active trials completed
- Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk NCT01764633 · started 2013 · scored riskier than 72% of active trials completed
- Vascular Effects of Alirocumab in Acute MI-Patients NCT03067844 · started 2017 · scored riskier than 72% of active trials completed
- Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody NCT02189837 · started 2014 · scored riskier than 6% 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.