Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Model scores of the 29,894 trials active now.
Model score 10% 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 6% of the time (816 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-07-14, after 2020-03-16 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 2021-07-14. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 15.4% (raises risk) · Sponsor's track record
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Sponsor's past trials: 1885 (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: pfdiabeticsafety tolerabilityplacebotype
Phrases that lowered it: participantsopenparticipantmetforminevaluate the -
Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 160 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 11.4% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Blinding: double (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Drug's FAERS reports marked serious: 87.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 9822 (lowers risk) · Drug's FDA history
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (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
- 1885 (typical: 32)
- Sponsor's past termination rate
- 15.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 160 (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
- 48994 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9822 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- clopidogrel
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
- 4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes NCT03538743 · started 2018 · scored riskier than 53% of active trials completed
- Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus NCT05158244 · started 2021 · scored riskier than 49% of active trials completed
- A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin NCT02053103 · started 2014 · scored riskier than 58% of active trials terminated
- A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus NCT01792635 · started 2012 · scored riskier than 58% of active trials terminated
- Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus NCT02175121 · started 2014 · scored riskier than 78% 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.