Bioequivalence Study of Pimavanserin 34 mg Capsule
Model scores of the 29,894 trials active now.
Model score 2% 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 2024-03-09, after 2024-01-11 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 2024-03-09. 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: priortime ofnonconditionmalignancy
Phrases that lowered it: healthysingle dosebioequivalenceperiodopen label -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
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Drug's FAERS reports marked serious: 47.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 29.6% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports before start: 32450 (raises risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 4511 (raises risk) · Drug's FDA history
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Sponsor's past trials: 12 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 45 (lowers risk) · Who can join
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Disease area, psychiatry: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 11 (lowers risk) · Sponsor's track record
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
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 12 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 32450 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4511 (typical: 412.5)
- Drug's FAERS reports marked serious
- 47.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- pimavanserin
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
- Bioequivalence Study of Perampanel Tablets 10 mg NCT06450236 · started 2023 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Perampanel Tablets 12 mg NCT06450223 · started 2023 · scored riskier than 0% of active trials completed
- BE Study of Metformin GSK 500mg NCT01710527 · started 2012 · scored riskier than 0% of active trials completed
- Food Effect and CYP1A2 Induction Study in Healthy Subjects NCT02168205 · started 2014 · scored riskier than 2% of active trials completed
- Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride NCT02943213 · started 2016 · scored riskier than 2% 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.