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.

MRC/BHF Heart Protection Study Collaborative Group BMC Clinical Pharmacology 2009 9:6   doi:10.1186/1472-6904-9-6

Open Data