Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease
Model scores of the 29,894 trials active now.
Model score 20% 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 15% of the time (446 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 2022-05-24, after 2012-08-16 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 2022-05-24. 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: cellmribraindlimaging
Phrases that lowered it: participantparticipantsscreeningdayallergy -
Sponsor's past termination rate: 14.9% (raises risk) · Sponsor's track record
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Collaborators: 10 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Primary purpose: prevention (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: triple (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Sponsor's past trials: 235 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 86 (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Minimum age: 1 (lowers risk) · Who can join
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Maximum age: 4.5 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 23.3% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 618 (raises risk) · Drug's FDA history
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Disease area, cardiovascular: Yes (raises 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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 10 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 4.5 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 235 (typical: 32)
- Sponsor's past termination rate
- 14.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 86 (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
- 2678 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 618 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology, 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
- Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II ) NCT04750707 · started 2021 · scored riskier than 46% of active trials completed
- Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II NCT02560935 · started 2016 · scored riskier than 85% of active trials completed
- Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea NCT01425307 · started 2011 · scored riskier than 88% of active trials terminated
- EXTEND EXpanding Treatment for Existing Neurological Disease NCT02556099 · started 2014 · scored riskier than 86% of active trials completed
- Voxelotor Neurocognitive Function Study NCT05228834 · started 2022 · scored riskier than 57% 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.