Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 4% 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 8% of the time (544 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 2012-09-30, after 2011-12-31 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 2012-09-30. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: paincanceragentschronicalpha
Phrases that lowered it: healthymalevolunteerspharmacokineticsinvestigator -
Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Minimum age: 21 (lowers risk) · Who can join
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Design: parallel (raises risk) · Design
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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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Maximum age: 60 (lowers risk) · Who can join
-
Collaborators: 2 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 2 (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 60 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- microcrystalline cellulose
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
- ACD440 Gel in Peripheral Neuropathic Pain NCT05416931 · started 2022 · scored riskier than 7% of active trials completed
- A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers NCT00912262 · started 2008 · scored riskier than 3% of active trials completed
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects NCT06155487 · started 2023 · scored riskier than 2% of active trials completed
- Titration Study of ABX-1431 NCT03447756 · started 2017 · scored riskier than 75% of active trials completed
- Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects NCT00962663 · started 2009 · scored riskier than 5% 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.