Table 4 Adverse event rates following alirocumab, placebo or ezetimibe treatments

TEAE (Any)

71.7 (67.7, 75.6)

2561/3425

68.4 (58.7, 78.2)

783/1007

1.00 (0.92, 1.10)

70.1 (62.9, 77.4)

605/862

1.01 (0.96, 1.07)

TEAE (Serious)

8.6 (4.5, 12.8)

455/3363

9.3 (1.2, 17.4)

158/992

0.94 (0.79, 1.12)

8.5 (4.1, 12.8)

91/862

1.03 (0.81, 1.31)

Leading to discontinuation

4.8 (2.7, 6.9)

187/3363

4.6 (2.1, 7.1)

56/992

1.07 (0.78, 1.47)

7.9 (3.9, 12.0)

69/862

0.83 (0.38, 1.83)

Death

0.5 (0.3, 0.7)

15/3363

1.2 (0.5, 1.8)

11/992

0.43 (0.19, 0.96)

0.5 (0.1, 1.0)

7/862

0.48 (0.16, 1.45)

CK >3 ULN

2.0 (1.0, 3.1)

114/3415

3.9 (2.0, 5.8)

54/1003

0.72 (0.52, 1.01)

2.4 (1.1, 3.7)

28/855

0.75 (0.46, 1.24)

ALT or AST >3 ULN

0.9 (0.5, 1.3)

25/1869

1.3 (0.2, 2.4)

2/218

0.95 (0.26, 3.47)

0.5 (0.2, 0.9)

4/858

1.91 (0.75, 4.88)

Musculoskeletal and connective-tissue disorders

16.7 (5.9, 27.6)

536/2450

17.3 (3.8, 30.7)

235/865

1.00 (0.87, 1.14)

22.3 (0, 46.5)

74/416

0.80 (0.60, 1.05)

Injection-site reactions

6.0 (3.8, 8.2)

225/3425

3.7 (2.5, 4.8)

42/1007

1.48 (1.05, 2.09)

3.0 (1.1, 4.9)

35/862

1.30 (0.88, 1.92)

Adjudicated cardiovascular events

2.6 (1.3, 3.9)

109/3130

3.2 (1.3, 5.0)

38/930

0.94 (0.64, 1.39)

1.2 (0.5, 1.9)

15/811

1.29 (0.71, 2.36)

Nervous system disorders

9.3 (4.2, 14.5)

338/2813

6.6 (0.0, 15.9)

145/865

0.97 (0.81, 1.17)

6.2 (4.2, 8.2)

34/536

0.85 (0.56, 1.30)

Gastrointestinal disorders

16.4 (9.4, 23.4)

332/1845

13.3 (5.1, 21.5)

158/865

1.01 (0.57, 1.80)

9.8 (1.6, 8.0)

5/51

1.77 (0.63, 4.91)

Neurocognitive disorders

0.6 (0.2, 1.1)

27/2923

0.6 (0.1, 1.0)

6/930

1.03 (0.23, 4.60)

1.3 (0.5, 2.1)

8/609

0.65 (0.22, 1.91)