A Ph 1 Study of Epanova® in Healthy Chineses
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-06-27, after 2018-06-04 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 2018-06-27. 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) (lowers risk) · Wording
Phrases that raised it: pastas determineddetermined bymultiplebp
Phrases that lowered it: healthypharmacokineticshcvsinglehepatitis -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past trials: 1504 (raises risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 126 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 2.1% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 7.9% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Primary purpose: basic science (lowers 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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1504 (typical: 32)
- Sponsor's past termination rate
- 7.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 126 (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
- 96 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 52 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- omega3 carboxylic acids
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
- A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects NCT01416207 · started 2011 · scored riskier than 3% of active trials completed
- Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects NCT04158102 · started 2019 · scored riskier than 1% of active trials completed
- Study of the Safety, Tolerability, Pharmacokinetic Characteristics of PA1010 in Healthy Subjects NCT05468060 · started 2020 · scored riskier than 1% of active trials completed
- A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants NCT06308523 · started 2024 · scored riskier than 4% of active trials completed
- Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of PA3670 Tablets in Chinese Healthy Subjects NCT05851261 · started 2023 · scored riskier than 1% 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.