Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
Model scores of the 29,894 trials active now.
Model score 18% 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 (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-03-21, after 2022-02-14 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 2024-03-21. 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) (raises risk) · Wording
Phrases that raised it: long termterm safetythe longcompletedmake
Phrases that lowered it: visitefficacy andparticipantperiodparticipants -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 13.3% (raises risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 75 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 0 (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
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 75 (typical: 32)
- Sponsor's past termination rate
- 13.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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, musculoskeletal
- 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
- Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis NCT05152173 · started 2021 · scored riskier than 35% of active trials completed
- Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease) NCT06151197 · started 2023 · scored riskier than 39% of active trials completed
- Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite) NCT03526549 · started 2018 · scored riskier than 58% of active trials completed
- EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) NCT02942160 · started 2016 · scored riskier than 53% of active trials completed
- Safety and Effectiveness of EN3835 in the Treatment of EFP in Women NCT03329989 · started 2017 · scored riskier than 26% 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.