Table 4

 Most commonly reported adverse events

MedDRA SOC preferred termIDEA-033 (n = 138)Celecoxib (n = 132)Placebo (n = 127)
MedDRA, Medical Dictionary for Regulatory Activities; NOS, not otherwise specified; SOC, System Organ Class.
Data are n (%). Patients who reported an adverse event more often than once during the study were only counted once.
Any SOC, any adverse events74 (53.6)66 (50.0)62 (48.8)
Gastrointestinal disorders, any adverse events13 (9.4)18 (13.6)12 (9.4)
    Abdominal pain, upper2 (1.4)4 (3.0)3 (2.4)
    Constipation3 (2.2)0 (0.0)1 (0.8)
    Diarrhoea NOS1 (0.7)2 (1.5)0 (0.0)
    Dyspepsia1 (0.7)4 (3.0)1 (0.8)
    Flatulence0 (0.0)2 (1.5)0 (0.0)
    Gastritis NOS3 (2.2)0 (0.0)3 (2.4)
    Nausea2 (1.4)3 (2.3)2 (1.6)
    Toothache0 (0.0)3 (2.3)1 (0.8)
Musculoskeletal and connective tissue disorders, any adverse events12 (8.7)19 (14.4)20 (15.7)
    Arthralgia3 (2.2)3 (2.3)4 (3.1)
    Back pain6 (4.3)6 (4.5)4 (3.1)
    Joint effusion2 (1.4)2 (1.5)1 (0.8)
    Sciatica0 (0.0)4 (3.0)1 (0.8)
Psychiatric disorders0 (0.0)6 (4.5)1 (0.8)
    Depression0 (0.0)3 (2.3)0 (0.0)
Respiratory, thoracic and mediastinal disorders, any adverse events17 (12.3)14 (10.6)10 (7.9)
    Nasopharyngitis10 (7.2)11 (8.3)6 (4.7)
Skin and subcutaneous tissue disorders, any adverse events39 (28.3)27 (20.5)28 (22.0)
    Dermatitis allergic2 (1.4)1 (0.8)0 (0.0)
    Erythema29 (21.0)18 (13.6)21 (16.5)
    Exanthema3 (2.2)2 (1.5)1 (0.8)
    Pruritus0 (0.0)5 (3.8)4 (3.1)
    Skin irritation2 (1.4)0 (0.0)0 (0.0)
    Urticaria NOS2 (1.4)1 (0.8)1 (0.8)