A Single Dose Evaluation of the Effects of Renal 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 (233 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: matchednon30 dayschildbearingwithin 30
Phrases that lowered it: healthysingle doseopen labelvaccine28 -
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
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Design: single group (raises risk) · Design
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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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Primary purpose: basic science (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 7 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 16 (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
- 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
- urogenital
- 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
- A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics NCT02286609 · started 2014 · scored riskier than 6% of active trials completed
- A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function NCT04476849 · started 2020 · scored riskier than 3% of active trials completed
- Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects NCT02313103 · started 2014 · scored riskier than 3% of active trials completed
- A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment NCT04859439 · started 2021 · scored riskier than 1% of active trials completed
- PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers NCT05431426 · started 2022 · 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.