Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 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 2014-02-28, 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 2014-02-28. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: therapycellcourseheartprior
Phrases that lowered it: gelpharmacokineticstreatment areatopicalpatient has -
Minimum age: 20 (lowers risk) · Who can join
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Primary purpose: not given (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: no FAERS history (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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- not given (typical: 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
- 20 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- none matched
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
- Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis NCT02559934 · started 2015 · scored riskier than 8% of active trials completed
- Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis NCT01516515 · started 2013 · scored riskier than 15% of active trials completed
- Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment NCT01493921 · started 2011 · scored riskier than 10% of active trials completed
- Safety and Efficacy Study of AM001 Cream in the Treatment of Actinic Keratosis NCT03210740 · started 2017 · scored riskier than 7% of active trials completed
- Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis NCT01265602 · started 2010 · scored riskier than 9% 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.