Skip to main content

Table 2 Clinical Adverse Experience Summary During the Active-Comparator Period (Weeks 6–52)

From: Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489]

 

Etoricoxib 30 mg

Etoricoxib 60 mg

Etoricoxib 90 mg

Diclofenac 150 mg

 

(N = 198)

(N = 102)

(N = 148)

(N = 102)

 

n (%)

n (%)

n (%)

n (%)

Clinical Adverse Experiences (AEs)

    

   All Clinical AEs

136 (68.7)

73 (71.6)

112 (75.7)

81 (79.4)

   Drug-related Clinical AEs†

34 (17.2)

18 (17.6)

34 (23.0)

25 (24.5)

   Serious AEs

12 (6.1)

3 (2.9)

5 (3.4)

7 (6.9)

   Discontinued due to an AE

6 (3.0)

6 (5.9)

10 (6.8)

12 (11.8)

Most Common Clinical AEs * ‡

    

   Dizziness

6 (3.0)

6 (5.9)

6 (4.1)

1 (1.0)

   Influenza-Like Disease

14 (7.1)

6 (5.9)

4 (2.7)

3 (2.9)

   Upper Respiratory Infection

32 (16.2)

14 (13.7)

28 (18.9)

21 (20.6)

   Diarrhea

12 (6.1)

1 (1.0)

7 (4.7)

13 (12.7)

   Heartburn

6 (3.0)

5 (4.9)

7 (4.7)

6 (5.9)

   Nausea

8 (4.0)

5 (4.9)

4 (2.7)

6 (5.9)

   Headache

10 (5.1)

6 (5.9)

1 (0.7)

3 (2.9)

   Urinary Tract Infection

10 (5.1)

3 (2.9)

5 (3.4)

5 (4.9)

Gastrointestinal (GI) Nuisance Symptoms %

    

   GI Nuisance Symptom AEs%

26 (13.1)

15 (14.7)

20 (13.5)

23 (22.5)

Discontinuations

0 (0.0)

1 (1.0)

2 (1.4)

4 (4.0)

Renovascular AEs

    

   Lower Extremity Edema

9 (4.5)

4 (3.9)

5 (3.4)

2 (2.0)

Discontinuations

1 (0.7)

0 (0.0)

0 (0.0)

0 (0.0)

   Congestive Heart failure

0 (0.0)

1 (1.3)

0 (0.0)

0 (0.0)

Discontinuations

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

   Hypertension

4 (2.0)

3 (2.9)

8 (5.4)

5 (4.9)

Discontinuations

1 (0.7)

0 (0.0)

1 (0.8)

1 (1.2)

  1. †Determined by the investigator to be possibly, probably, or definitely related to treatment
  2. * Incidence 5.0% or more in any treatment group
  3. ‡ Hypertension is among the most common AEs, but is listed under the Renovascular AEs section of the table.
  4. %Includes abdominal pain, acid reflux, dyspepsia, epigastric discomfort, heartburn, nausea, and vomiting