Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II )
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-03-10, after 2021-03-09 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 2025-03-10. 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: braininjuryimagingcellstroke
Phrases that lowered it: singleparticipantsopen labelbloodkg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Collaborators: 6 (lowers risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 17.5% (lowers risk) · Drug's FDA history
-
Minimum age: 3 (lowers risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Drug's FAERS reports before start: 13795 (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 79.4% (lowers risk) · Drug's FDA history
-
Maximum age: 9 (raises risk) · Who can join
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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 6 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 3 (typical: 18)
- Maximum age
- 9 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 13795 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1925 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- 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
- Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II NCT02560935 · started 2016 · scored riskier than 85% of active trials completed
- Moderate Dose Hydroxyurea for Secondary Stroke Prevention in Children With Sickle Cell Disease in Sub-Saharan Africa NCT02675790 · started 2017 · scored riskier than 84% of active trials completed
- EXTEND EXpanding Treatment for Existing Neurological Disease NCT02556099 · started 2014 · scored riskier than 86% of active trials completed
- Hydroxyurea Management in Kids: Intensive Versus Stable Dosage Strategies NCT03020615 · started 2017 · scored riskier than 75% of active trials completed
- Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease NCT01389024 · started 2012 · scored riskier than 72% 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.