Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 7% 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 (257 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-02-17, after 2019-12-31 start.
Reason given by the sponsor: “efficacy”
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 2020-02-17. 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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Sponsor's past termination rate: 47.5% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: therapycelliiacutegvhd
Phrases that lowered it: kgparticipantsto evaluatedrugsingle -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 32 (lowers risk) · Sponsor's track record
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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: 18 (raises risk) · Who can join
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 12.0% (lowers risk) · Drug's FDA history
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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 marked serious: 77.7% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 328240 (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
- 5 (typical: 1)
Who can join
- Minimum age
- 0.08 (typical: 18)
- Maximum age
- 18 (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
- 59 (typical: 32)
- Sponsor's past termination rate
- 47.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 32 (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
- 328240 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 55342 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- itacitinib, methylprednisolone, 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
- Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD NCT02614612 · started 2015 · scored riskier than 69% of active trials completed
- A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease NCT04220632 · started 2020 · scored riskier than 69% of active trials terminated
- Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects NCT03497273 · started 2018 · scored riskier than 73% of active trials completed
- GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease NCT03139604 · started 2017 · scored riskier than 78% of active trials completed
- GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease NCT03320642 · started 2018 · scored riskier than 74% 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.