Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (111 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-02-28, after 2015-01-31 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 2019-02-28. 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: eligiblepatients musttreatingbreastcells
Phrases that lowered it: participantstractclinicalthe effecthepatic -
Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 36.2% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 57 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 205 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 17609 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 148296 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 5.6% (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Blinding: none (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Number of arms: 1 (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
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 205 (typical: 32)
- Sponsor's past termination rate
- 15.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 57 (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
- 148296 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17609 (typical: 412.5)
- Drug's FAERS reports marked serious
- 36.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology
- Drugs matched to FDA substances
- methylprednisolone, natalizumab
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
- Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease NCT02133924 · started 2016 · scored riskier than 93% of active trials completed
- Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT) NCT01757197 · started 2013 · scored riskier than 95% of active trials terminated
- A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease NCT02245412 · started 2014 · scored riskier than 49% of active trials terminated
- 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
- Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD NCT02406651 · started 2016 · scored riskier than 96% 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.