Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (107 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-07-30, after 2021-05-03 start.
Reason given by the sponsor: “enrollment”
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 2022-07-30. 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: chronicriskcontrolledthrombocytopeniapost
Phrases that lowered it: malefostamatinibmmhghepaticline -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 19.3% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 57.3% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 180 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 17.8% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 43676 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 8246 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 704 (raises risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Blinding: none (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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 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
- 704 (typical: 32)
- Sponsor's past termination rate
- 19.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 180 (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
- 43676 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8246 (typical: 412.5)
- Drug's FAERS reports marked serious
- 57.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- fostamatinib, 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
- Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL) NCT05177211 · started 2022 · scored riskier than 79% of active trials completed
- Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms NCT05127174 · started 2022 · scored riskier than 53% of active trials terminated
- Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis NCT03386214 · started 2018 · scored riskier than 42% of active trials terminated
- Single-Agent Glasdegib In Patients With Myelofibrosis Previously Treated With Ruxolitinib NCT02226172 · started 2014 · scored riskier than 89% of active trials terminated
- Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis NCT01369498 · started 2011 · scored riskier than 91% 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.