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Table 3 Safety in THOMAS-1 and THOMAS-2

From: Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting

 

THOMAS-1

THOMAS-2

All

Autoinjector (n = 74)

PFS (n = 75)

Autoinjector (n = 82)

AMD (n = 82)

(n = 313)

Total treatment-emergent AEs

20 (27.0)

22 (29.3)

27 (32.9)

21 (25.6)

90 (28.8)

 Grade 3 or 4

2 (2.7)

3 (4.0)

1 (1.2)

1 (1.2)

7 (2.2)

 AEs leading to study drug discontinuation

1 (1.4)

2 (2.7)

1 (1.2)

0

4 (1.3)

  Serious

1 (1.4)

1 (1.3)

0

0

2 (0.7)

  Nonserious

0

1 (1.3)

1 (1.2)

0

2 (0.7)

 Serious AEs

2 (2.7)

3 (4.0)

1 (1.2)

0

6 (1.9)

 Adverse device effects

0

0

2 (2.4)

1 (1.2)

3 (1.0)

 Injection-site reactions

0

0

0

1 (1.2)

1 (0.3)

  1. Values are presented as number (percent) of patients
  2. AEs adverse events, AMD automated minidoser, PFS prefilled syringe