Table 2.

Summary of adverse events in Norwegian patients with ankylosing spondylitis stratified according to treatment group (celecoxib 200 or 400 mg daily [qd] or diclofenac 50 mg three times daily [tid]): safety population.

Adverse event	Celecoxib		Diclofenac group n = 115
	200 mg group n = 107	400 mg group n = 108
Adverse events	56 (52)	56 (52)	64 (56)
Drug-related adverse events	41 (38)	31 (29)	49 (43)
Drug withdrawn due to adverse events
Temporarily	1 (0.9)	0 (0)	3 (2.6)
Permanently	12 a (11.2)	14 (13.0)	15 (13.0)
Serious adverse events	1 (0.9)	2 (1.9)	2 (1.7)
Deaths	0 (0)	0 (0)	0 (0)
Adverse events occurring in ≥2% of patients in any treatment group (system organ class)b
Gastrointestinal disorders
Abdominal discomfort	3 (2.8)	3 (2.8)	3 (2.6)
Abdominal distension	2 (1.9)	3 (2.8)	3 (2.6)
Abdominal pain NOS	7 (6.5)	3 (2.8)	2 (1.7)
Diarrhoea	5 (4.7)	4 (3.7)	8 (7.0)
Dyspepsia	10 (9.3)	6 (5.6)	13 (11.3)
Flatulence	2 (1.9)	0 (0)	3 (2.6)
Gastrointestinal disorder NOS	3 (2.8)	1 (0.9)	0 (0)
Nausea	4 (3.7)	4 (3.7)	8 (7.0)
General/administration site disorders
Fatigue	4 (3.7)	4 (3.7)	3 (2.6)
Infection and infestations
Nasopharyngitis	4 (3.7)	6 (5.6)	2 (1.7)
Nervous system disorders
Dizziness	1 (0.9)	2 (1.9)	4 (3.5)
Headache	4 (3.7)	5 (4.6)	4 (3.5)
Skin and subcutaneous tissue disorders
Pruritus	3 (2.8)	1 (0.9)	2 (1.7)

Data presented as n (%) patients.

^aOne patient withdrew due to an adverse event of headache; however, onset of the headache was prior to the first dose of study medication and it was therefore not considered to be treatment emergent. Because the investigator listed the patient’s reason for discontinuation as ‘due to an adverse event’, it remains as such within patient disposition.

^bIf a patient had > 1 adverse event within a system organ class, that patient was counted once in the overall incidence for that system organ class.

NOS, not otherwise specified.