Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease

NCT00929695 on ClinicalTrials.gov Phase 3 Fred Hutchinson Cancer Center (academic or other) Started 2009-06-30 Completed

Riskier than 36% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2015-12-14, after 2009-06-30 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2015-12-14. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: donorgvhdgraftacutetransplant
Phrases that lowered it: kgand safetyefficacy andsafety ofphase iii
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 15.7% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Minimum age: not given (raises risk) · Who can join
Primary purpose: supportive care (lowers risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Number of arms: 2 (raises risk) · Design
Collaborators: 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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: supportive care (typical: treatment)
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: not given (typical: 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: 80 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 24 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 30876 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5450 (typical: 412.5)
Drug's FAERS reports marked serious: 80.7% (typical: 85.6%)
Drug's FAERS reports with a death: 15.7% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: methylprednisolone, methylprednisolone hemisuccinate, prednisone

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

To Compare the Efficacy of the Addition of Methotrexate (MTX) to Current Standard Acute Graft-versus-host Disease (GVHD) First-line Treatment With Corticosteroids NCT03371667 · started 2018 · scored riskier than 54% of active trials completed
Acute Graft-versus-Host Disease Treatment (BMT CTN 0802) NCT01002742 · started 2010 · scored riskier than 95% of active trials completed
In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus NCT01453140 · started 2011 · scored riskier than 94% of active trials terminated
A Study of Rituximab Combined With Prednisone for the Initial Treatment of Chronic Graft Versus Host Disease (cGVHD) NCT01066598 · started 2010 · scored riskier than 99% of active trials terminated
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

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.