Table 2.

Nonfatal Serious Adverse Events and Fatal Events, According to Study Group.

Event	Simvastatin (N = 430)	Placebo (N = 447)	P Value
Nonfatal serious adverse event — no. of events/person-yr
Acute exacerbation	0.32	0.32	0.99
Respiratory event
Pneumonia	0.01	<0.01	0.56
Chronic bronchitis	0.02	0.02	0.53
Other	0.01	0.01	0.75
Cancer
Lung cancer	0.02	0.03	0.81
Other	0.03	0.03	0.21
Cardiovascular event
Cardiac event	0.04	0.01	0.35
Other	0.03	0.08	0.23
Gastrointestinal tract event	0.05	0.02	0.02
Other	0.11	0.11	0.99
Total	0.63	0.62	0.96
Fatal event — no. of patients (%)
Acute exacerbation	6 (1.4)	5 (1.1)	0.72
Other respiratory event
Pneumonia	1 (0.2)	1 (0.2)	0.99
Chronic bronchitis	0	2 (0.4)	0.16
Other	6 (1.4)	4 (0.9)	0.49
Cancer
Lung cancer	3 (0.7)	4 (0.9)	0.73
Other	0	1 (0.2)	0.33
Cardiovascular event
Heart	0	1 (0.2)	0.33
Other	4 (0.9)	3 (0.7)	0.67
Gastrointestinal tract event	0	3 (0.7)	0.09
Other	8 (1.9)	6 (1.3)	0.56
Total	28 (6.5)	30 (6.7)	0.89