Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions
Model scores of the 29,894 trials active now.
Model score 13% 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 (313 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-05-02, after 2015-12-28 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 2024-05-02. 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) (raises risk) · Wording
Phrases that raised it: cancercellstherapychemotherapyenrollment
Phrases that lowered it: participantsscreening90investigatorbased on -
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
-
Collaborators: 3 (lowers risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: single (lowers risk) · Design
-
Disease area, urogenital: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 19.5% (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 93.9% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 16 (typical: 32)
- Sponsor's past termination rate
- 12.5% (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 28988 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4691 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- fluorouracil, imiquimod
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
- Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions NCT02135419 · started 2014 · scored riskier than 42% of active trials completed
- VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2 NCT03499795 · started 2018 · scored riskier than 65% of active trials completed
- Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3) NCT03100045 · started 2017 · scored riskier than 63% of active trials completed
- Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women NCT01461096 · started 2012 · scored riskier than 16% of active trials completed
- Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection NCT03202992 · started 2017 · scored riskier than 16% 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.