A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone
Model scores of the 29,894 trials active now.
Model score 6% 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 16% of the time (81 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-11-20, after 2022-10-28 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 2023-11-20. 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) (lowers risk) · Wording
Phrases that raised it: childrensystemicskintacrolimus30
Phrases that lowered it: effectrhinitisasthmaand safetydermatitis -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 153 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 14.1% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: 16 (raises risk) · Who can join
-
Blinding: double (raises risk) · Design
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Minimum age: 2 (lowers risk) · Who can join
-
Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor's past trials: 134 (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 207954 (lowers 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- 16 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 134 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 153 (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
- 207954 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 22075 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology
- Drugs matched to FDA substances
- hydrocortisone, tacrolimus
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
- Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis NCT00833079 · started 2008 · scored riskier than 10% of active trials completed
- Emollients in the Management of Atopic Dermatitis NCT01779258 · started 2013 · scored riskier than 16% of active trials completed
- To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin) NCT02601703 · started 2015 · scored riskier than 5% of active trials completed
- Effect of OC000459 on Moderate to Severe Atopic Dermatitis NCT02002208 · started 2013 · scored riskier than 7% of active trials completed
- DMT210 Topical Gel in the Treatment of Atopic Dermatitis NCT02949960 · started 2016 · scored riskier than 7% 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.