Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the phase 4 registry

Table 4 AEs considered treatment-related, by current treatment group

MedDRA system organ class/preferred term^a	nsNSAID (n = 225^b) n (%)	Celecoxib (n = 68^b) n (%)	Off NSAID^c(n = 79) n (%)
Patients with at least 1 treatment-related AE	48 (21.3)	13 (19.1)	6 (7.6)
GI disorders (as shown below)	36 (16.0)	10 (14.7)	3 (3.8)
Abdominal pain	17 (7.6)	5 (7.4)	0
Nausea	8 (3.6)	3 (4.4)	1 (1.3)
Diarrhea	6 (2.7)	2 (2.9)	0
Dyspepsia	5 (2.2)	2 (2.9)	1 (1.3)
Gastroesophageal reflux disease	6 (2.7)	0	0
Constipation	4 (1.8)	0	1 (1.3)
Abdominal pain lower	3 (1.3)	0	0
Abdominal pain upper	1 (0.4)	2 (2.9)	0
Vomiting	0	1 (1.5)	1 (1.3)
Abdominal distension	1 (0.4)	0	0
Feces discolored	0	1 (1.5)	0
Gastritis	1 (0.4)	0	0
General disorders and administration site conditions	3 (1.3)	0	0
Immune system disorders (drug hypersensitivity)	1 (0.4)	0	0
Infections and infestations	1 (0.4)	0	1 (1.3)
Injury, poisoning, and procedural complications	4 (1.8)	0	0
Investigations	2 (0.9)	0	0
Blood pressure increased	1 (0.4)	0	0
Blood urea increased	1 (0.4)	0	0
Weight decreased	1 (0.4)	0	0
Metabolism and nutrition disorders	5 (2.2)	1 (1.5)	2 (2.5)
Musculoskeletal and connective tissue disorders	1 (0.4)	0	0
Nervous system disorders	6 (2.7)	0	0
Renal and urinary disorders	0	2 (2.9)	0
Reproductive system and breast disorders	0	1 (1.5)	0
Skin and subcutaneous tissue disorders	4 (1.8)	0	2 (2.5)
Vascular disorders	1 (0.4)	0	0

^aPatients are counted only once in each preferred term category, and only once in each system organ class category.
^bPatients appear in both treatment groups if they switched treatments.
^cOff NSAID is defined as 29 or more days after last dose of final study medication.
Abbreviations: AE Adverse event, MedDRA Medical Dictionary for Regulatory Activities, GI Gastrointestinal, NSAID Nonsteroidal anti-inflammatory drug.

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