Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 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
Terminated on 2017-05-03, after 2013-10-31 start.
Reason given by the sponsor: “enrollment”
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 2017-05-03. 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: to determineor equalequal tokidneydetermine whether
Phrases that lowered it: breastsingle dosestudy tosettingacetaminophen -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 17.9% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports before start: 94122 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 13171 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 94122 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13171 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- 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
- Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery NCT05764707 · started 2020 · scored riskier than 81% of active trials completed
- Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications NCT02156154 · started 2014 · scored riskier than 49% of active trials completed
- A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain NCT02254525 · started 2012 · scored riskier than 18% of active trials terminated
- Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients NCT01394718 · started 2011 · scored riskier than 54% of active trials completed
- Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery NCT03679013 · started 2019 · scored riskier than 99% 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.