A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects
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 8% of the time (544 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-06-08, after 2021-05-19 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 2021-06-08. 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: subjects withpurposethe subjectmultiplepressure
Phrases that lowered it: healthythe pharmacokineticskgparticipantssingle -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 26.3% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 38 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 5.4% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 76.3% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (lowers risk) · Design
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Disease area, psychiatry: 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.
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
- 4 (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
- 19 (typical: 32)
- Sponsor's past termination rate
- 26.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 38 (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
- 2670 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 753 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- brivaracetam
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
- The Pharmacokinetics, and Safety of Brexpiprazole Tablets in Chinese Healthy Subjects NCT03734302 · started 2019 · scored riskier than 1% of active trials completed
- The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects NCT03734354 · started 2019 · scored riskier than 0% of active trials completed
- A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body NCT05633862 · started 2023 · scored riskier than 7% of active trials completed
- A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants NCT05805904 · started 2023 · scored riskier than 4% of active trials completed
- Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers NCT01922349 · started 2013 · scored riskier than 8% 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.