Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 18% of the time (243 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 2018-05-24, after 2014-08-23 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 2018-05-24. 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: cell000dlpatientsdisease
Phrases that lowered it: participantsbloodmedical historyphysicaltests -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past termination rate: 4.7% (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 276 (lowers risk) · Sponsor's track record
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Minimum age: 15 (raises risk) · Who can join
-
Maximum age: 99 (lowers risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 87.1% (lowers risk) · Drug's FDA history
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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
- 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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 15 (typical: 18)
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 276 (typical: 32)
- Sponsor's past termination rate
- 4.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3676 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 582 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- hydroxyurea
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
- Treatment of Adult Patients With Hemoglobin SC Disease (SCYTHE) NCT02640573 · started 2015 · scored riskier than 93% of active trials terminated
- Decitabine for High-Risk Sickle Cell Disease NCT01375608 · started 2011 · scored riskier than 66% of active trials completed
- Treatment of Hemoglobin SC Disease With Hydroxyurea NCT02336373 · started 2014 · scored riskier than 90% of active trials terminated
- Hydroxyurea and Transfusion NCT03644953 · started 2018 · scored riskier than 54% of active trials completed
- Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia NCT01506544 · started 2011 · scored riskier than 23% 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.