Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (139 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-08-13, after 2018-09-26 start.
Reason given by the sponsor: “other”
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 2020-08-13. 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: chronicsicklebloodweighttransfusion
Phrases that lowered it: the effecteffect ofpatientpatientsevaluate the -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Sponsor's past trials: 1519 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 10.3% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 125 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Sponsor's past termination rate: 7.8% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 73.0% (lowers risk) · Drug's FDA history
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Minimum age: 2 (lowers risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1519 (typical: 32)
- Sponsor's past termination rate
- 7.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 125 (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
- 17906 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3853 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- ticagrelor
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
- PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4) NCT03492931 · started 2018 · scored riskier than 30% of active trials completed
- Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients NCT03474965 · started 2018 · scored riskier than 86% of active trials completed
- Safety, Tolerability and Pharmacokinetics of FTX-6058 NCT04586985 · started 2020 · scored riskier than 8% of active trials completed
- Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease NCT04514510 · started 2020 · scored riskier than 83% 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
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.