Table 3 Adverse event rates at 12-week follow-up following different dosages of evolocumab treatments

TEAE (Any)

52.1 (42.9, 61.3)

565/1228

52.0 (43.1, 60.9)

496/1095

1.01 (0.92, 1.10)

TEAE (Serious)

1.4 (0.8, 1.9)

23/1228

2.5 (1.6, 3.3)

30/1095

0.69 (0.39, 1.23)

Leading to discontinuation

1.4 (0.6, 2.2)

26/1228

1.8 (0.8, 2.9)

26/1095

0.94 (0.54, 1.64)

Death

NA

0/1228

NA

1/1095

NA

CK >5 ULN

0.5 (0.1, 0.9)

8/1183

0.1 (0, 0.3)

2/1050

1.58 (0.44, 5.75)

ALT or AST >3 ULN

0.4 (0.2, 0.7)

5/1183

0.5 (0.1, 0.8)

5/1050

0.70 (0.20, 2.44)

Adjudicated cardiovascular events

1.1 (0.2, 2.0)

3/288

1.5 (0.3, 2.6)

6/285

0.56 (0.17, 1.92)

Musculoskeletal and connective-tissue disorders

3.9 (1.0, 6.9)

21/421

8.0 (3.4, 12.5)

30/386

0.63 (0.29, 1.34)

Back pain

3.6 (1.0, 6.3)

20/830

2.4 (1.4, 3.5)

20/788

1.09 (0.42, 2.87)

Arthralgia

1.8 (0.9, 2.7)

13/687

1.5 (0.6, 2.3)

10/678

1.27 (0.56, 2.87)

Muscle spasms

2.0 (0.5, 3.5)

18/823

1.4 (0.4, 2.5)

15/780

1.10 (0.56, 2.20)

Myalgia

1.3 (0, 2.7)

11/414

2.3 (0.4, 4.2)

12/378

0.91 (0.40, 2.06)

Headache

3.1 (1.7, 4.4)

40/1142

2.7 (1.3, 4.2)

26/1043

1.40 (0.84, 2.33)

Injection-site reactions

2.0 (0.9, 3.1)

18/577

2.4 (0.8, 4.0)

19/540

0.94 (0.50, 1.78)

Gastrointestinal disorders

4.9 (2.3, 7.5)

35/580

5.4 (2.5, 8.2)

28/488

1.13 (0.68, 1.87)

Nasopharyngitis

4.9 (2.5, 7.4)

36/613

4.1 (1.7, 6.6)

24/488

1.10 (0.63, 1.89)

Influenza

1.2 (0.1, 2.4)

9/350

2.5 (0.4, 5.4)

8/225

0.19 (0.03, 1.10)

Upper respiratory tract infection

4.6 (2.2, 6.9)

14/247

4.8 (1.2, 8.4)

6/123

1.30 (0.46, 3.70)