Edoxaban versus Warfarin in Patients with Atrial Fibrillation
2013 · paper · Clinical trials
A randomized, double-blind trial of two once-daily edoxaban regimens versus warfarin in 21,105 patients with atrial fibrillation. Both regimens were noninferior for stroke or systemic embolism and caused less major bleeding and cardiovascular death.
1 finding
Wording Table 2 footnote §, attached to the row "Intention-to-treat population in the overall study period§", reads "derived from a Cox model that included only patients who received the randomly assigned treatment", which conflicts with the intention-to-treat definition (all randomized patients, N=7036/7035/7034).
- p. 7 Table 2, footnote §
derived from a Cox model that included only patients who received the randomly assigned treatment
- p. 6 Table 2, row flagged §
Intention-to-treat population in the overall study period§
- p. 8 Figure 1 caption
in the intention-to-treat population (all patients who underwent randomization)
Only the authors can say what is right here.
Judge's note: Page 6 shows § on the intention-to-treat row under column headers N=7036/7035/7034. Page 7 shows the footnote as quoted. The Figure 1 caption (page 8) defines intention-to-treat as "all patients who underwent randomization". A model limited to patients who received treatment would be the modified intention-to-treat set (7012/7012/7002 per footnote †). The footnote's next sentence, about other analyses being adjusted for stratification variables, suggests the intended meaning was a model with treatment as its only term. The authors should clarify.
Second check: another model agreed
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3 minor (typos and the like; most checked by the judge only)
Wording Table 3 footnote * says net clinical outcomes "are presented for the overall treatment period (which began at the time of randomization)", whereas the Methods call the period starting at randomization the "overall study period" and define the treatment period as starting at the first dose.
- p. 9 Table 3, footnote *
presented for the overall treatment period (which began at the time of randomization)
- p. 3 Methods, Statistical Analysis
The treatment pe-riod was defined as the period between adminis-tration of the first dose of the study drug
- p. 4 Methods, Statistical Analysis (continuation below Table 1)
study period (i.e., from randomization to the end of the treatment period)
- p. 3 Methods, Statistical Analysis
The treatment period was defined as the period between adminis-
Only the authors can say what is right here.
Judge's note: Page 9 footnote reads as quoted, and the same footnote says the treatment period "began when the first dose of study drug was administered". The Methods (pages 3–4) and the Figure 1 caption use "overall study period" for the period from randomization. This is a terminology inconsistency; "overall study period" is probably meant, but the authors should confirm, given the safety-cohort column headers (N=7012/7012/7002).
Second check: another model agreed
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Wording Text says "The rates of major bleeding and death were also similar among the treatment groups during this transition period" and "no increase in the risk of stroke or bleeding when patients in the edoxaban groups made the transition", but Table 3 transition bleeding counts are 6 and 5 (warfarin), 4 and 6 (high-dose), 5 and 13 (low-dose).
- p. 10 Discussion, right column
there was no increase in the risk of stroke or bleeding when patients in the edoxaban groups made the transition
- p. 5 Results, Primary End Point, last paragraph
The rates of major bleeding and death were also similar among the treatment groups during this transition period.
- p. 9 Table 3, Bleeding during transition to open-label oral anticoagulation therapy, Day 15–30 row
13
- p. 10 Discussion
no increase in the risk of stroke or bleeding when patients in the edoxaban groups made the tran-
Judge's note: Table 3 (page 9) shows Day 1–14: 6, 4, 5 and Day 15–30: 5, 6, 13, giving totals of 11, 10 and 18. The low-dose count is higher, most visibly in days 15–30 (13 vs 5). The counts are small and the article gives no denominators or test, so "similar" may be defensible. The unqualified wording for both edoxaban groups is a minor consistency point.
Second check: another model agreed
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Typo Misplaced hyphen: "6.79% with low dose-edoxaban (hazard ratio," should read "low-dose edoxaban".
- p. 7 Secondary and Other Efficacy Outcomes, second paragraph
6.79% with low dose-edoxaban (hazard ratio,
- p. 7 Secondary and other efficacy outcomes, net clinical outcome sentence
6.79% with low dose-edoxaban
Judge's note: On the page 7 image the phrase sits mid-line as "low dose-edoxaban", so it is not a line-break hyphen. The paper writes "low-dose edoxaban" elsewhere.
Second check: none (judge only)