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. Author manuscript; available in PMC: 2021 Jul 21.
Published in final edited form as: N Engl J Med. 2020 Nov 13;384(3):216–228. doi: 10.1056/NEJMoa2028220

Table 3. Clinical Outcomes with Aspirin or Placebo.

Outcome Aspirin
(N = 2860)
Placebo
(N = 2853)
Hazard Ratio
(95% CI)*
Primary outcome
Death from cardiovascular causes, myocardial infarction, or stroke — no. (%) 116 (4.1) 134 (4.7) 0.86 (0.67–1.10)
Secondary Outcome
Death from cardiovascular causes, myocardial infarction, stroke, or cancer — no. (%) 153 (5.3) 177 (6.2) 0.86 (0.69–1.07)
Components of the primary and secondary outcomes
Death from cardiovascular causes — no. (%) 85 (3.0) 100 (3.5) 0.85 (0.64–1.14)
Myocardial infarction — no. (%) 22 (0.8) 21 (0.7) 1.04 (0.57–1.89)
Stroke — no. (%) 23 (0.8) 39 (1.4) 0.58 (0.35–0.98)
Cancer — no. (%) 38 (1.3) 46 (1.6) 0.83 (0.54–1.27)
Other efficacy outcomes
Death from any cause — no. (%) 145 (5.1) 167 (5.9) 0.87 (0.70–1.09)
First and recurrent events of the primary outcome
      No. of participants with ≥1 event 116 134
      No. of participants with ≥2 events 8 10
      Total no. of events 124 144 0.86 (0.67–1.11)
First and recurrent events of the secondary outcome
      No. of participants with ≥1 event 153 177
      No. of participants with ≥2 events 12 17
      Total no. of events 165 194 0.85 (0.68–1.06)‡
*

The widths of the confidence intervals have not been adjusted for multiplicity, so the intervals should not be used to infer definitive treatment effects.

Death from cardiovascular causes included confirmed death from cardiovascular causes (in 68 participants in the aspirin group and in 69 in the placebo group) and death from an unknown cause, which was categorized according to the protocol definition as presumed death from cardiovascular causes (in 17 and 31 participants, respectively).

The analysis was conducted with the use of a proportional-means model.