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Table 4 Summary of AEs during Part I

From: Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial

 

Placebo n = 118

Etoricoxib 60 mg n = 819

Etoricoxib 90 mg n = 467

N (%) with AEs

30 (25.4)

248 (30.3)

168 (36.0)

N (%) with AEs determined by the investigator to be drug related

8 (6.8)

64 (7.8)

59 (12.4)

N (%) with serious AEs

0 (0.0)

7 (0.9)

2 (0.4)

N (%) who discontinued due to AEs

4 (3.4)

27 (3.3)

24 (5.1)

Most Common AEs (incidence >2 % in one or more treatment groups)

 Upper abdominal pain

2 (1.7)

12 (1.5)

11 (2.4)

 Nausea

0 (0.0)

19 (2.3)

5 (1.1)

 Peripheral edema

0 (0.0)

8 (1.0)

10 (2.1)

 Nasopharyngitis

1 (0.8)

14 (1.7)

14 (3.0)

 Blood pressure increased

2 (1.7)

10 (1.2)

13 (2.8)

 Headache

6 (5.1)

25 (3.1)

17 (3.6)

 Hypertension

0 (0.0)

20 (2.4)

15 (3.2)

Prespecified AEs of Interest

 Hypertension-related AEsa

2 (1.7)

34 (4.2)

26 (5.6)

 Discontinuation due to hypertension-related AEs

2 (1.7)

3 (0.4)

11(2.4)

 Edema-related AEsb

0 (0.0)

8 (1.0)

10 (2.1)

 Discontinuation due to edema-related AEs

0 (0.0)

0 (0.0)

2 (0.4)

 Congestive heart failure, pulmonary edema, or cardiac failure

0 (0.0)

0 (0.0)

0 (0.0)

  1. aHypertension-related AEs included development of hypertension or worsening of preexisting hypertension
  2. bEdema-related AEs included edema, lower extremity edema, and peripheral edema