P3592Safety analysis of rivaroxaban: a pooled analysis of the global XANTUS programme (real-world, prospective, observational studies for stroke prevention in patients with atrial fibrillation)
Bibliographic record
Abstract
Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are increasingly used for stroke prevention in atrial fibrillation (AF) but their real-world safety has not been fully explored. The real-world XANTUS study showed low rates of stroke and major bleeding in patients with AF treated with the NOAC rivaroxaban in Europe and Canada. XANAP and XANTUS-EL were sister studies in different geographical regions. Purpose: To assess the global safety profile of rivaroxaban in routine practice through a pooled analysis of the XANTUS programme studies, collecting information on AF patients in 47 countries. Methods: A pre-planned pooled analysis of the prospective, observational XANTUS, XANAP and XANTUS-EL studies of unselected patients with AF newly starting rivaroxaban for stroke prevention was performed. Patients were followed for 1 year, at ∼3-month intervals, or for ≥30 days after permanent discontinuation. Primary outcomes were major bleeding, adverse events (AEs) or serious AEs (SAEs) and all-cause mortality. Secondary outcomes included symptomatic thromboembolic events and non-major bleeding. Treatment-emergent major outcomes were adjudicated by a central committee.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.037 | 0.044 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.034 |
| Bibliometrics | 0.005 | 0.005 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".