Efficacy and Safety Study of Topical Rapamycin Associated With Pulsed Dye Laser in Patients With Sturge-Weber Syndrome
Model scores of the 29,894 trials active now.
Model score 32% for any early termination, 21% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 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 2012-12-31, after 2011-01-31 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 2012-12-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: greateror equalequal toheartstudy drug
Phrases that lowered it: and safetytopicalpatients whofaceefficacy and -
Sponsor's past termination rate: 44.4% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Primary purpose: not given (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 98.3% (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 16.1% (lowers risk) · Drug's FDA history
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Maximum age: 65 (lowers risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 13 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 9 (raises risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 9 (typical: 32)
- Sponsor's past termination rate
- 44.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 13 (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
- 1031 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 155 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology
- Drugs matched to FDA substances
- sirolimus
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
- Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome NCT03047980 · started 2017 · scored riskier than 93% of active trials completed
- Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex NCT03363763 · started 2017 · scored riskier than 14% of active trials terminated
- Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas NCT03660930 · started 2019 · scored riskier than 62% of active trials terminated
- SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors NCT03433183 · started 2019 · scored riskier than 96% of active trials completed
- A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors NCT02110069 · started 2017 · scored riskier than 98% 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.