Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
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 6% of the time (238 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-04-25, after 2023-02-15 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 2023-04-25. 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: priorsubjectdiseaseglucosecondition
Phrases that lowered it: healthybioequivalenceopen labelperiodsingle -
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
-
Phase: 3 (lowers risk) · Design
-
Primary purpose: other (lowers risk) · Design
-
Drug's FAERS reports marked serious: 19.9% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 1.4% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports in the prior 12 months: 7355 (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports before start: 127218 (raises risk) · Drug's FDA history
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Maximum age: 45 (lowers 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
- 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
- 5 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 127218 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7355 (typical: 412.5)
- Drug's FAERS reports marked serious
- 19.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology, musculoskeletal
- Drugs matched to FDA substances
- apremilast
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 Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects NCT06592300 · started 2024 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects NCT06043297 · started 2023 · scored riskier than 0% of active trials completed
- A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions NCT05665283 · started 2022 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions NCT03561558 · started 2018 · scored riskier than 0% of active trials completed
- The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects NCT01905553 · started 2013 · 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.