Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddy's Under Fasting Conditions
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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2008-03-31, after 2008-01-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2008-03-31. 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: subjectssubjectpriormodifying drugsdisease
Phrases that lowered it: bioavailabilityhealthyvolunteerscrossovermg -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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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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Has a data monitoring committee: Yes (raises risk) · Design
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Responsible party: not given (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 49 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 26.0% (raises risk) · Drug's FDA history
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Maximum age: 45 (lowers risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 96.3% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Blinding: none (lowers risk) · Design
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Sponsor's past trials: 114 (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
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 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
- 114 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 49 (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
- 4018 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1493 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- tacrolimus
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
- Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting Conditions NCT01132027 · started 2008 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Tacrolimus in Healthy Volunteers NCT04725682 · started 2021 · scored riskier than 0% of active trials completed
- Drug Interaction Study of Isavuconazole and Tacrolimus NCT01535547 · started 2011 · scored riskier than 2% of active trials completed
- A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule NCT01039883 · started 2009 · scored riskier than 1% of active trials completed
- Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions NCT01270308 · started 2008 · 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.