Table 4: Summary of Treatment-Emergent Adverse Events (AE), Safety Population

BMI <30 kg/m2 BMI ≥30 kg/m2
Continuous Use Celecoxib 200 mg qd n=209 n (%) Intermittent Use Celecoxib 200 mg qd n=205 n (%) Continuous Use Celecoxib 200 mg qd n=222 n (%) Intermittent Use Celecoxib 200 mg qd n=222 n (%)
Total no. patients with AE 114 (54.5) 121 (59.0) 131 (59.0) 130 (58.6)
AE ≥2% Patients in Either Treatment Group by Preferred Term
Headache 33 (15.8) 32 (15.6) 32 (14.4) 36 (16.2)
Back pain 10 (4.8) 20 (9.8) 10 (4.5) 11 (5.0)
Arthralgia 9 (4.3) 14 (6.8) 8 (3.6) 11 (5.0)
Nasopharyngitis 7 (3.3) 8 (3.9) 12 (5.4) 12 (5.4)
Diarrhea 1 (0.5) 11 (5.4) 6 (2.7) 6 (2.7)
Pain in extremity 9 (4.3) 10 (4.9) 9 (4.1) 11 (5.0)
Dyspepsia 6 (2.9) 3 (1.5) 11 (5.0) 3 (1.4)
Upper respiratory tract infection 7 (3.3) 9 (4.4) 7 (3.2) 10 (4.5)
Hypertension 2 (1.0) 9 (4.4) 7 (3.2) 4 (1.8)
Upper abdominal pain 3 (1.4) 9 (4.4) 4 (1.8) 1 (0.5)
Sinusitis 5 (2.4) 1 (0.5) 6 (2.7) 9 (4.1)
Musculoskeletal pain 4 (1.9) 3 (1.5) 3 (1.4) 9 (4.1)
Insomnia 3 (1.4) 6 (2.9) 8 (3.6) 2 (0.9)
Edema peripheral 3 (1.4) 5 (2.4) 1 (0.5) 7 (3.2)
Bronchitis 2 (1.0) 2 (1.0) 1 (0.5) 7 (3.2)
Muscle spasms 7 (3.3) 1 (0.5) 3 (1.4) 4 (1.8)
Dizziness 6 (2.9) 6 (2.9) 2 (0.9) 2 (0.9)
Nausea 2 (1.0) 6 (2.9) 3 (1.4) 3 (1.4)
Abdominal pain 4 (1.9) 2 (1.0) 6 (2.7) 2 (0.9)
Contusion 1 (0.5) 1 (0.5) 2 (0.9) 6 (2.7)
Myalgia 4 (1.9) 4 (2.0) 6 (2.7) 5 (2.3)
Toothache 1 (0.5) 4 (2.0) 2 (0.9) 2 (0.9)
Fatigue 0 (0) 6 (2.9) 6 (2.7) 3 (1.4)
Pain 4 (1.9) 6 (2.9) 2 (0.9) 3 (1.4)
Influenza 5 (2.4) 4 (2.0) 5 (2.3) 5 (2.3)
Vomiting 1 (0.5) 4 (2.0) 4 (1.8) 2 (0.9)
Viral infection 0 (0) 4 (2.0) 3 (1.4) 0 (0)
Rash 0 (0) 4 (2.0) 1 (0.5) 3 (1.4)