OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
Model scores of the 29,894 trials active now.
Model score 22% 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 21% of the time (63 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-06-14, after 2019-10-10 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 2024-06-14. 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) (raises risk) · Wording
Phrases that raised it: extensionadalzheimercompletedsuicidal
Phrases that lowered it: participantdrugevaluate theto evaluateurine -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Has a data monitoring committee: not given (lowers risk) · Design
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Design: single group (raises 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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Minimum age: 55 (raises risk) · Who can join
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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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Collaborators: 2 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Phase: 2/3 (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Maximum age: 85 (raises risk) · Who can join
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Keywords listed: 0 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (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
- 2/3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 55 (typical: 18)
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001 NCT04575259 · started 2019 · scored riskier than 50% of active trials completed
- Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease NCT02244541 · started 2014 · scored riskier than 30% of active trials completed
- An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease NCT02756858 · started 2016 · scored riskier than 91% of active trials completed
- 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) NCT02916056 · started 2016 · scored riskier than 99% of active trials terminated
- ANAVEX2-73 for Treatment of Early Alzheimer's Disease NCT03790709 · started 2018 · scored riskier than 23% 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.