In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 1% 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 2019-01-29, after 2018-12-26 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 2019-01-29. 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: imagingperformance30nonand females
Phrases that lowered it: healthyopen labelcrossoversingleevaluate the -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 5.2% (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 59.0% (lowers risk) · Drug's FDA history
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Minimum age: 30 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 6.5% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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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
-
Number of arms: 4 (lowers risk) · Design
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Blinding: none (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
- 4 (typical: 2)
- Allocation
- non randomized (typical: 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
- 30 (typical: 18)
- Maximum age
- 65 (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
- 96 (typical: 32)
- Sponsor's past termination rate
- 5.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 76866 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11332 (typical: 412.5)
- Drug's FAERS reports marked serious
- 59.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- budesonide
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
- Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation NCT05570539 · started 2022 · scored riskier than 0% of active trials completed
- A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers NCT01566760 · started 2012 · scored riskier than 1% of active trials completed
- Bioequivalence Study of Budesonide From Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) Versus Uceris 9 mg Extended Release Tablets (Man. for: Salix Pharm., a Division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by License of Cosmo Tech. Ltd., Ireland, Product of France) NCT04854538 · started 2020 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition NCT01741623 · started 2012 · scored riskier than 0% of active trials completed
- ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects NCT05668429 · started 2022 · scored riskier than 0% 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.