A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 2% 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
Completed on 2014-11-30, after 2013-11-30 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 2014-11-30. 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) (lowers risk) · Wording
Phrases that raised it: heartand necktime ofhead andsurgery
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacyto evaluate -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 8.5% (lowers risk) · Drug's FDA history
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Design: single group (raises 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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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 96.7% (raises risk) · Drug's FDA history
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Maximum age: 15 (raises risk) · Who can join
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Minimum age: 1 (lowers risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 1 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 467 (raises 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 15 (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
- 57 (typical: 32)
- Sponsor's past termination rate
- 5.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 1452 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 467 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- remifentanil
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
- A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery NCT06391931 · started 2024 · scored riskier than 7% of active trials completed
- Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL NCT03682302 · started 2019 · scored riskier than 18% of active trials completed
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants NCT03139500 · started 2017 · scored riskier than 5% of active trials terminated
- Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL NCT03485014 · started 2018 · scored riskier than 4% of active trials completed
- Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects NCT00652028 · started 2008 · scored riskier than 74% 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.