Serious adverse events after randomization were uncommon
( Table 4 ). Rates of death (ie, the percentages of participants who
died) were similar in the any-dose aspirin and placebo groups
(0.95% vs 0.85%, respectively; P = .85), as were the rates of myocardial
infarction (0.48% vs 0.31%; P = .57). Of the 12 participants
who had a stroke, all were randomly assigned to an aspirin group
( P = .002). Most of the stroke cases were apparently thrombotic
events; only one — in a participant with a subarachnoid hemorrhage
— was thought to be hemorrhagic. Rates of major bleeding
were similar among participants allocated to any-dose aspirin
and those allocated to placebo (2.50% and 2.79%, respectively;
P = .64). Rates of new cancer diagnoses (ie, the percentages of
participants who received a new diagnosis of any invasive cancer)
were not statistically significantly different in the any-dose aspirin
and placebo groups (2.62% vs 1.86%, respectively; P = .18),
although the invasive cancer rate in the any-dose aspirin group was
somewhat higher than that in the placebo group.