Skip to main content

Table 2 Adverse events during the extension study (safety analysis set)

From: Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

 

Maintenance group (n = 70)

Switch group (n = 78)

Number

%

Number

%

All AEs

49

70.0

55

70.5

All ADRs

20

28.6

26

33.3

Serious AEs

6

8.6

8

10.3

Serious ADRs

3

4.3

4

5.1

Any AEs leading to discontinuation

1

1.4

3

3.8

Any AEs leading to temporary drug interruption

13

18.6

8

10.3

AEs experienced by ≥ 5% of patients in either group (by preferred term)

 Upper respiratory tract infection

4

5.7

9

11.5

 Nasopharyngitis

7

10.0

4

5.1

 Arthralgia

3

4.3

8

10.3

 Cough

3

4.3

4

5.1

Active tuberculosis

0

0

0

0

Injection site reaction

1

1.4

5

6.4

  1. ADR adverse drug reaction, AE adverse event