A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 4% 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 2010-10-31, after 2008-02-29 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 2010-10-31. 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: pftolerability pharmacokineticsmultiplesafety tolerabilitydose of
Phrases that lowered it: alzheimermild toto moderatewith mildallergic -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 14.7% (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 246 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Minimum age: 50 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Responsible party: not given (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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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: 85 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Number of arms: 6 (lowers risk) · Design
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Sponsor's past trials: 360 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Keywords listed: 0 (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 50 (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
- 360 (typical: 32)
- Sponsor's past termination rate
- 14.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 246 (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
- Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease NCT01125631 · started 2010 · scored riskier than 71% of active trials completed
- Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease NCT00722046 · started 2008 · scored riskier than 38% of active trials completed
- A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease NCT00945672 · started 2009 · scored riskier than 42% of active trials completed
- Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease NCT00733642 · started 2008 · scored riskier than 55% of active trials completed
- Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers NCT01005862 · started 2010 · scored riskier than 44% 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.