Safety and Pharmacokinetics of VNRX-5133 in the Epithelial Lining Fluid of Healthy Adult Subjects
Model scores of the 29,894 trials active now.
Model score 3% 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 2019-04-01, after 2019-03-14 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 2019-04-01. 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: priorbpto admissionadmission tonegative
Phrases that lowered it: healthypharmacokineticsopen labeldrugmale -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Drug's FAERS reports with a death: 26.3% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 94.2% (raises risk) · Drug's FDA history
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Number of arms: 1 (raises 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 3 (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
- 6912 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1216 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- cefepime
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
- VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment NCT03690362 · started 2018 · scored riskier than 2% of active trials completed
- Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects NCT05068947 · started 2021 · scored riskier than 4% of active trials completed
- Safety and Pharmacokinetics of VT-1598 NCT04208321 · started 2020 · scored riskier than 5% of active trials completed
- Relative Bioavailability and Food Effect Study of CVN424 NCT05635461 · started 2022 · scored riskier than 1% of active trials completed
- A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study NCT03602300 · started 2018 · 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.