Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Model scores of the 29,894 trials active now.
Model score 12% 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 19% of the time (731 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-03-11, after 2015-08-10 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 2016-03-11. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectsmultipletolerabilitydiseasekey
Phrases that lowered it: healthysafety ofpharmacokineticefficacysmoker -
Sponsor's past termination rate: 14.5% (raises risk) · Sponsor's track record
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Phase: 2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
-
Sponsor's past trials: 802 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Blinding: triple (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 239 (raises risk) · Sponsor's track record
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Number of arms: 5 (lowers risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: 80 (raises risk) · Who can join
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
- 2
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 60 (typical: 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
- 802 (typical: 32)
- Sponsor's past termination rate
- 14.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 239 (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, psychiatry
- Drugs matched to FDA substances
- none matched
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 Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease NCT03131453 · started 2017 · scored riskier than 17% of active trials terminated
- Safety, Tolerability, and Pharmacokinetics Study of NDX-1017 NCT03298672 · started 2017 · scored riskier than 14% of active trials completed
- A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia NCT02185053 · started 2014 · scored riskier than 23% of active trials completed
- A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease NCT02565511 · started 2015 · scored riskier than 86% of active trials terminated
- Safety, Tolerability, and Pharmacokinetics Study of ATH-1020 NCT05169671 · started 2022 · scored riskier than 8% 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.