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. 2021 Mar 16;325(11):1061–1073. doi: 10.1001/jama.2021.1489

Table 3. Incidence and Relative Hazards of AF Among Participants Randomized to Vitamin D3 vs Placebo.

End points Vitamin D3 (n = 12 553) Placebo (n = 12 566) Vitamin D3 vs placebo
No. of events Total person-years Events per 1000 person-years No. of events Total person-years Events per 1000 person-years Difference in events per 1000 person-years (95% CI) Hazard ratio (95% CI)a P value
Primary end point
All incident AF 469 65 046 7.2 431 65 137 6.6 0.6 (−0.3 to 1.5) 1.09 (0.96-1.25) .19
Sensitivity analyses of primary end point
AF events excluding those with symptoms preceding randomization 438 64 948 6.7 404 65 046 6.2 0.5 (−0.3 to 1.4) 1.09 (0.95-1.25) .22
AF events excluding those detected by CMS linkage data alone 373 64 727 5.8 361 64 919 5.6 0.2 (−0.6 to 1.0) 1.04 (0.90-1.20) .60
AF events excluding atrial flutter alone and postoperative AFb 404 64 815 6.2 380 64 962 5.8 0.4 (−0.5 to 1.2) 1.07 (0.93-1.23) .36
AF events excluding those confirmed by medical record aloneb 343 64 671 5.3 313 64 790 4.8 0.5 (−0.3 to 1.2) 1.10 (0.95-1.28) .22
On-treatment analysisc 383 50 540 7.6 336 48 640 6.9 0.7 (−0.4 to 1.7) 1.09 (0.94-1.27) .24
Secondary end points
Paroxysmal AF 267 65 046 4.1 259 65 137 4.0 0.1 (−0.6 to 0.8) 1.03 (0.87-1.23) .71
Nonparoxysmal AF 188 65 046 2.9 158 65 137 2.4 0.5 (−0.1 to 1.0) 1.20 (0.97-1.48) .10

Abbreviations: AF, atrial fibrillation; CMS, Centers for Medicare & Medicaid Services.

a

The hazard ratio for each intervention was estimated in Cox models using indicators for treatment group, controlling for the second intervention, age, and sex.

b

Post hoc analyses.

c

Adherence-based analyses that censored follow-up data when a participant discontinued trial capsules or began taking more than 800 IU/d of nonstudy vitamin D3.