A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 1% 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 2015-02-28, after 2014-12-31 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 2015-02-28. 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: nonmatchedtransplant30 dayssubject
Phrases that lowered it: healthysingle dosevaccineopen labelsmokers -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 43.8% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Maximum age: 80 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 97.7% (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 10.3% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: basic science (lowers risk) · Design
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Sponsor's past trials: 16 (lowers risk) · Sponsor's track record
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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
- 2
- Allocation
- non randomized (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
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (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
- 16 (typical: 32)
- Sponsor's past termination rate
- 43.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 751 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 156 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- deflazacort
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
- Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant NCT06928779 · started 2024 · scored riskier than 3% of active trials completed
- Fruquintinib Hepatic Impairment Study NCT05216367 · started 2022 · scored riskier than 2% of active trials completed
- DZD9008 PK Study in Hepatic Impairment Subjects NCT06084104 · started 2023 · scored riskier than 4% of active trials completed
- Study of Single-dose DS-3201b in Participants With Hepatic Impairment NCT04276662 · started 2019 · scored riskier than 4% of active trials completed
- A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment NCT04859426 · started 2021 · 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.