First Line Therapy for High Risk Acute GVHD
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 8% 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 (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-06-30, after 2019-08-25 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 2023-06-30. 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: donoracutegvhdtransplantationto determine
Phrases that lowered it: efficacy andand safetythe efficacyinterfere withsafety of -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Collaborators: 5 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 58.7% (lowers risk) · Drug's FDA history
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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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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports with a death: 18.9% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 14 (raises risk) · Who can join
-
Drug's FAERS reports before start: 28746 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 6734 (lowers risk) · Drug's FDA history
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Maximum age: 65 (lowers risk) · Who can join
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
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 5 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 14 (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
- 27 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 37 (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
- 28746 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6734 (typical: 412.5)
- Drug's FAERS reports marked serious
- 58.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ruxolitinib
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
- Low Dose Ruxolitinib in Combination With Methylprednisolone NCT04397367 · started 2019 · scored riskier than 49% of active trials completed
- Ruxolitinib and Steroid As First Line Therapy for Acute GVHD NCT03701698 · started 2018 · scored riskier than 28% of active trials terminated
- Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation NCT02913261 · started 2017 · scored riskier than 47% of active trials completed
- A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) NCT02953678 · started 2016 · scored riskier than 87% of active trials completed
- Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease NCT03491215 · started 2019 · scored riskier than 77% 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.