Table 1.
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.