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. 2009 Mar 31;9:6. doi: 10.1186/1472-6904-9-6

Table 3.

Serious adverse events considered (before unblinding) to be probably due to study simvastatin

Event Simvastatin-allocated Placebo-allocated
(n = 10269) (n = 10267)
Myopathy/rhabdomyolysis* 7 (0.1%) 2 (0.0%)
Muscle pain/weakness** 0 (0.0%) 1 (0.0%)
Hepatitis 1 (0.0%) 1 (0.0%)
GI haemorrhage 1 (0.0%) 0 (0.0%)
Renal failure 0 (0.0%) 1 (0.0%)
Neurological 0 (0.0%) 2 (0.0%)

* Includes 1 patient in each group taking non-study statin in addition to study treatment

** CK <10 × ULN