Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Model scores of the 29,894 trials active now.
Model score 8% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-03-31, after 2016-06-30 start.
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 2017-03-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ocularophthalmicglaucomarandomizationiop
Phrases that lowered it: screeninginvestigatepainand safetyefficacy and -
Drug's FAERS reports marked serious: 33.5% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 2.6% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: not given (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 1492 (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
- 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
- 7 (typical: 1)
Who can join
- Minimum age
- 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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 1492 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 359 (typical: 412.5)
- Drug's FAERS reports marked serious
- 33.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- loteprednol etabonate
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
- Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation NCT02163824 · started 2014 · scored riskier than 14% of active trials completed
- Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease NCT02813265 · started 2016 · scored riskier than 6% of active trials completed
- Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease NCT02819284 · started 2016 · scored riskier than 7% of active trials completed
- Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease NCT02188160 · started 2014 · scored riskier than 13% of active trials completed
- KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children NCT03596723 · started 2018 · scored riskier than 14% 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.