Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Model scores of the 29,894 trials active now.
Model score 24% 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 26% of the time (851 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-05-07, after 2015-07-31 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 2020-05-07. 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: chemotherapypatients mustventricularof childbearingpotential
Phrases that lowered it: psoriasisamldrugsautoimmunesuspected -
Sponsor's past termination rate: 27.7% (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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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 171 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Keywords listed: 22 (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 24.0% (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 109711 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 93.0% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 22 (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
- 542 (typical: 32)
- Sponsor's past termination rate
- 27.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 171 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 8 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 109711 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 27048 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- cytarabine, cytosine, dexamethasone, dobesilate, idarubicin, methylprednisolone, methylprednisolone hemisuccinate, nivolumab
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
- Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS) NCT02599649 · started 2016 · scored riskier than 94% of active trials terminated
- Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia NCT02397720 · started 2015 · scored riskier than 79% of active trials completed
- Nivolumab in AML in Remission at High Risk for Relapse NCT02532231 · started 2015 · scored riskier than 74% of active trials completed
- Phase I Study to Assess the Tolerability and Efficacy of Nivolumab in Patients With Hematologic Malignancies NCT02985554 · started 2017 · scored riskier than 86% of active trials terminated
- Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant NCT02846376 · started 2019 · scored riskier than 83% 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.