Rectal Safety and Acceptability Study of Tenofovir 1% Gel
Model scores of the 29,894 trials active now.
Model score 5% 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 11% of the time (918 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 2011-07-31, after 2010-10-31 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 2011-07-31. 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: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: dlml mincreatinineplaceboct
Phrases that lowered it: participantparticipantsgelproductsscreening -
Primary purpose: other (lowers risk) · Design
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Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 17.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 94.8% (raises risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Collaborators: 2 (lowers risk) · Design
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Blinding: single (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 2 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 7 (lowers risk) · Sponsor's track record
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 14.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 1487 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 194 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- tenofovir
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 Study to Compare Three Different Formulations of Tenofovir 1% Gel When Administered Rectally NCT01575405 · started 2013 · scored riskier than 3% of active trials completed
- Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet NCT00984971 · started 2009 · scored riskier than 8% of active trials completed
- An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations NCT01575418 · started 2013 · scored riskier than 3% of active trials completed
- Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults NCT02346084 · started 2015 · scored riskier than 4% of active trials completed
- Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT) NCT04032717 · started 2019 · scored riskier than 5% 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.