Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people

Table 1 Reasons for patients who entered the run-in period not proceeding to the Randomisation appointment

Reason	Phase of Run-in period
	Placebo	Active	Unknown	Overall
Screening blood results	1132	-	-	1132
Cholesterol <3.5 mmol/L	220	-	-	220
Liver function test abnormality*	656	-	-	656
CK>3 × ULN	78	-	-	78
Creatinine >200 μmol/L	192	-	-	192
Participant vetoed or advised against by patient's physician	797	577	1	1375
Randomisation appointment cancelled	1100	1139	296	2535
MI, angina or stroke during run-in	7	24	0	31
Died or cancer diagnosed	18	29	2	49
Myopathy	0	2	0	2
Other adverse event	193	217	0	410
Patient wishes	854	848	0	1702
Other or unknown reason	28	19	294	341
Failed to attend randomisation appointment (no reason given)	0	0	3129	3129
Any of the above	3029	1716	3426	8171

*ALT >1.5 × ULN, or >1.0 = 1.5 × ULN and AST, GGT or ALP >2 × ULN or any of AST, GGT or ALP >4 × ULN.