Statistical Analysis Plan for the Treatment of Cardiovascular disease with low dose Rivaroxaban in Advanced CKD (TRACK) trial
Bibliographic record
Abstract
1 Abstract The Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK) trial is a randomised quadruple-blind phase IV clinical trial to determine whether low-dose rivaroxaban (2.5 mg daily) reduces the risk of major adverse cardiovascular events compared to placebo. It aims to recruit approximately 2,000 patients with advanced chronic kidney disease (stages 4, 5 or dialysis-dependent) and an elevated cardiovascular risk. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variable collected in the trial. The primary outcome is the time from randomisation to first occurrence of major cardiovascular event including death from cardiovascular cause, myocardial infarction, stroke or peripheral artery disease event. The primary analysis will consist in a Cox proportional hazard model adjusted for stratification variables. The analysis plan also includes planned sensitivity analyses including covariate adjustments and subgroup analyses.
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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 | 0.035 | 0.083 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.007 |
| Insufficient payload (model declined to judge) | 0.083 | 0.008 |
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".