Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (41 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-02-02, after 2019-02-21 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 2023-02-02. 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: donorgvhdmalignancygraftchronic
Phrases that lowered it: and safetysafety ofsinglelabelpk -
Sponsor's past termination rate: 15.0% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Drug's FAERS reports marked serious: 58.7% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 162 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 17 (raises risk) · Who can join
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Sponsor's past trials: 1198 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 0.08 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 19.0% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 6701 (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
- 1/2 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 0.08 (typical: 18)
- Maximum age
- 17 (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
- 1198 (typical: 32)
- Sponsor's past termination rate
- 15.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 162 (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
- 25284 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6701 (typical: 412.5)
- Drug's FAERS reports marked serious
- 58.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology
- 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
- Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant NCT03774082 · started 2020 · scored riskier than 70% of active trials completed
- A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) NCT03112603 · started 2017 · scored riskier than 63% of active trials completed
- 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
- A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002) NCT04934670 · started 2022 · scored riskier than 60% 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.