Acetaminophen vs Indomethacin in Treating hsPDA
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-09-30, after 2016-06-30 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 2018-09-30. 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: leftactivelifeivheart
Phrases that lowered it: the efficacykgdayacetaminophenfindings -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 6.2% (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 14.8% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: single (lowers risk) · Design
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Drug's FAERS reports before start: 186996 (lowers risk) · Drug's FDA history
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Maximum age: 0.62 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 74.1% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 46110 (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Minimum age: 0.42 (lowers 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 0.42 (typical: 18)
- Maximum age
- 0.62 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 32
- Sponsor's past termination rate
- 6.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (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
- 186996 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 46110 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- acetaminophen, indomethacin
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
- Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus NCT03701074 · started 2018 · scored riskier than 92% of active trials terminated
- Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants NCT05493540 · started 2021 · scored riskier than 44% 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
- Paracetamol in Patent Ductus Arteriosus NCT02422966 · started 2015 · scored riskier than 46% of active trials completed
- An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants NCT00750581 · started 2008 · scored riskier than 15% 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.