DOSE Trial of Opioid Sparing Effect
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-11-06, after 2019-07-18 start.
Reason given by the sponsor: “enrollment”
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 2020-11-06. 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: hoursventilationmechanicaldouble blindchildren
Phrases that lowered it: effectreceiptaminotransferasetriallight -
Sponsor's past termination rate: 16.8% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Collaborators: 4 (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Drug's FAERS reports with a death: 37.0% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 168 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 749 (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Maximum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 78.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 11861 (lowers risk) · Drug's FDA history
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Minimum age: not given (raises risk) · Who can join
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
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 4 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 749 (typical: 32)
- Sponsor's past termination rate
- 16.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 168 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 103545 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11861 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 37.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dexmedetomidine, fentanyl
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
- Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects NCT00875550 · started 2010 · scored riskier than 76% of active trials completed
- Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure NCT02996058 · started 2016 · scored riskier than 17% of active trials completed
- Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01) NCT03645603 · started 2018 · scored riskier than 55% of active trials terminated
- Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children NCT04027829 · started 2019 · scored riskier than 25% of active trials completed
- Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU NCT00747721 · started 2008 · scored riskier than 83% 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.