Codeine in Mechanically Ventilated Neonates
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (106 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 2013-03-06, after 2008-08-31 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 2013-03-06. 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: patientsfailurepatientreceivinglimit
Phrases that lowered it: metabolismsubjectdrugthe studyrelevant -
Sponsor's past termination rate: 3.4% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 23 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 0.08 (raises risk) · Who can join
-
Responsible party: principal investigator (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 1 (raises risk) · Design
-
Drug's FAERS reports with a death: 22.0% (raises risk) · Drug's FDA history
-
Sponsor's past trials: 87 (lowers risk) · Sponsor's track record
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
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.08 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 87 (typical: 32)
- Sponsor's past termination rate
- 3.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 23 (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
- 1409 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 189 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- codeine
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
- Pharmacokinetics of Oral Morphine and Pharmacogenomics of CYP2D6 and UGT2B7, in an Urban Pediatric Population Presenting for Elective Surgery NCT01071499 · started 2010 · scored riskier than 4% of active trials completed
- A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain NCT01676493 · started 2012 · scored riskier than 52% of active trials terminated
- Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery. NCT01094522 · started 2010 · scored riskier than 79% of active trials completed
- Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients NCT01117376 · started 2010 · scored riskier than 30% of active trials terminated
- Steady State Study of Codeine Sulfate NCT01009853 · started 2008 · scored riskier than 2% 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.