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Table 3 Summary of treatment-emergent adverse events in the etanercept and placebo groups

From: Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study

 

Double blind (week 8)

Open label (week 16)

Escape arm

Finding

Etanercept 50 mg(n  = 42)

Placebo(n  = 48)

Etanercept 50 mg/etanercept 50 mg(n  = 31)

Placebo/etanercept 50 mg(n  = 33)

Etanercept 50 mg/etanercept 50 mg(n  = 6)

Placebo/etanercept 50 mg(n  = 11)

Any adverse event

34 (81.0)

26 (54.2)

12 (38.7)

17 (51.5)

6 (100.0)

9 (81.8)

Serious adverse event

1 (2.4)

2 (4.2)

0

1 (3.0)

0

0

Adverse event leading to discontinuation

4 (9.5)

0

0

2 (6.1)

1 (16.7)

0

Infections

11 (26.2)

10 (20.8)

6 (19.4)

8 (24.2)

2 (33.3)

4 (36.4)

Serious infections

0

0

0

0

0

0

  1. Data presented as number of patients (%).