The Preterm Infants' Paracetamol Study
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 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 2024-08-08, after 2013-08-31 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 2024-08-08. 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: painpulmonaryeffectshypertensionhours
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacykg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 3.7% (lowers risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 18.0% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Minimum age: not given (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 27 (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 14232 (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 92235 (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 81.1% (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 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
- 27 (typical: 32)
- Sponsor's past termination rate
- 3.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (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
- 92235 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 14232 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- acetaminophen
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
- Extremely Low Gestatonal Age Infants' Paracetamol Study NCT03641209 · started 2018 · scored riskier than 29% of active trials completed
- Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus NCT04037514 · started 2017 · scored riskier than 19% of active trials completed
- Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates NCT00969176 · started 2009 · scored riskier than 20% of active trials completed
- Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen NCT04459117 · started 2020 · scored riskier than 35% of active trials completed
- Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus NCT03648437 · started 2018 · scored riskier than 18% of active trials terminated
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.