The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole
Model scores of the 29,894 trials active now.
Model score 7% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-01-26, after 2020-06-15 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 2022-01-26. 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: monthsfirst administrationpriorhourstransplantation
Phrases that lowered it: pharmacokineticsinvestigate theto investigatehypertensionthe effect -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 9.2% (raises risk) · Sponsor's track record
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Minimum age: 45 (lowers risk) · Who can join
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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: 10.6% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 97 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 75.7% (lowers risk) · Drug's FDA history
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Primary purpose: basic science (lowers risk) · Design
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Disease area, neurology: No (lowers 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 45 (typical: 18)
- Maximum age
- 75 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 87 (typical: 32)
- Sponsor's past termination rate
- 9.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 97 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 488574 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 54681 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- midazolam, omeprazole, warfarin
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
- Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride NCT04621669 · started 2021 · scored riskier than 8% of active trials completed
- A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects NCT05045313 · started 2021 · scored riskier than 1% of active trials completed
- A Phase I Study of SHR1459 in Healthy Subjects NCT04455100 · started 2020 · scored riskier than 1% of active trials completed
- HMPL-689 Drug Interaction Study With CYP3A Inhibitor/CYP2C9 Inhibitor/CYP3A Inducer/PPI NCT05602597 · started 2022 · scored riskier than 1% of active trials completed
- Phase 1 Study of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers NCT06318845 · started 2024 · scored riskier than 0% 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.