Efficacy and Safety of Dapagliflozin in Patients with Non-alcoholic Steatohepatitis
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 26% of the time (136 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-07-23, after 2022-08-01 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 2024-07-23. 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
-
Sponsor's past termination rate: 0.6% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientspatientstagebiopsytype diabetes
Phrases that lowered it: and safetyefficacy andsafety ofevaluate theto evaluate -
Phase: 2 (raises risk) · Design
-
Sponsor's past trials: 701 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 643 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 9.4% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers 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
-
Number of arms: 4 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 76.7% (lowers risk) · Drug's FDA history
-
Blinding: none (raises risk) · Design
-
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 9 (typical: 1)
Who can join
- Minimum age
- 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
- 701 (typical: 32)
- Sponsor's past termination rate
- 0.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 643 (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
- 54305 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3713 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- dapagliflozin, pioglitazone
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
- The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus NCT06117137 · started 2023 · scored riskier than 7% of active trials completed
- Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus NCT05232071 · started 2022 · scored riskier than 24% of active trials completed
- Dapagliflozin Efficacy and Action in NASH NCT03723252 · started 2019 · scored riskier than 26% of active trials completed
- Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease NCT01963845 · started 2014 · scored riskier than 62% of active trials completed
- SGLT2 Inhibitors and Metformin on Metabolism and Non-Alcoholic SteatoHepatitis NCT02696941 · started 2016 · scored riskier than 10% 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.