A Single Arm Pilot Study of Azacitidine in Myelodysplastic Syndromes (MDS) / Acute Myeloid Leukaemia (AML), With Eltrombopag Support for Thrombocytopenia
Model scores of the 29,894 trials active now.
Model score 31% 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 26% of the time (3,728 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 2015-05-31, after 2010-12-31 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 2015-05-31. 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: chemotherapypatientmdsconditionsyndrome
Phrases that lowered it: subjectshealthyscreeningevaluate theto evaluate -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 43.0% (raises risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Phase: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 3 (raises risk) · Sponsor's track record
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Collaborators: 2 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 93.2% (raises risk) · Drug's FDA history
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Keywords listed: 0 (raises risk) · Design
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Drug's FAERS reports before start: 1816 (raises risk) · Drug's FDA history
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Disease area, dermatology: No (lowers risk) · Disease area
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
- sponsor
- Collaborators
- 2 (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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 1816 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1053 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 43.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- azacitidine, eltrombopag
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
- Safety Study of Eltrombopag Combined With Azacitidine to Treat Myelodysplastic Syndrome (MDS) NCT01481220 · started 2011 · scored riskier than 74% of active trials completed
- Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia NCT01286038 · started 2011 · scored riskier than 73% of active trials terminated
- A Pilot Study of a Thrombopoietin-Receptor Agonist, Eltrombopag, in Patients With Low to Int-2 Risk Myelodysplastic Syndrome (MDS) NCT00961064 · started 2011 · scored riskier than 63% of active trials completed
- A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS) NCT02158936 · started 2014 · scored riskier than 73% of active trials terminated
- Eltrombopag With or Without Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS) NCT01893372 · started 2013 · scored riskier than 97% 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.