PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 16% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-06, after 2021-09-14 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 2023-10-06. 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: celltherapycancercellshours
Phrases that lowered it: the effecteffect oftrialthe efficacyupper -
Sponsor's past termination rate: 26.6% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 193 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 19181 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 92.4% (raises risk) · Drug's FDA history
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Sponsor's past trials: 994 (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 132142 (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports with a death: 22.8% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers 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
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 994 (typical: 32)
- Sponsor's past termination rate
- 26.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 193 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 9 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 132142 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 19181 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- cefepime, cilastatin, daptomycin, imipenem, linezolid, meropenem, piperacillin tazobactam, relebactam
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
- Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021) NCT03969901 · started 2019 · scored riskier than 92% of active trials completed
- Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013) NCT02452047 · started 2015 · scored riskier than 44% of active trials completed
- Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance NCT04147221 · started 2020 · scored riskier than 52% of active trials completed
- Study of the Safety, Tolerability, and Efficacy of Relebactam (MK-7655) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone to Treat Complicated Intra-Abdominal Infection [cIAI] (MK-7655-004) NCT01506271 · started 2012 · scored riskier than 72% of active trials completed
- Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam NCT03485950 · started 2018 · scored riskier than 95% 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.