Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
Model scores of the 29,894 trials active now.
Model score 15% 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 10% of the time (1,463 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 2013-05-31, after 2010-09-30 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 2013-05-31. 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: determinedialysisinjurypatientadministration
Phrases that lowered it: formulationtrialaminotransferaseefficacy andand safety -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
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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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Drug's FAERS reports with a death: 9.3% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
-
Drug's FAERS reports marked serious: 63.9% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
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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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Minimum age: 12 (raises risk) · Who can join
-
Drug's FAERS reports before start: 5938 (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 12 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 24 (typical: 32)
- Sponsor's past termination rate
- 4.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- 5938 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 525 (typical: 412.5)
- Drug's FAERS reports marked serious
- 63.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- acetylcysteine, edetic acid
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
- Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine NCT02206178 · started 2013 · scored riskier than 2% of active trials completed
- Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients NCT00598559 · started 2008 · scored riskier than 97% of active trials completed
- Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients NCT00598702 · started 2008 · scored riskier than 85% of active trials completed
- Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose NCT05517668 · started 2022 · scored riskier than 92% of active trials terminated
- 13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF NCT02786836 · started 2016 · scored riskier than 73% 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.