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

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

MedDRA system organ class/preferred terma nsNSAID (n = 225b) n (%) Celecoxib (n = 68b) n (%) Off NSAIDc(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
  1. aPatients are counted only once in each preferred term category, and only once in each system organ class category.
  2. bPatients appear in both treatment groups if they switched treatments.
  3. cOff NSAID is defined as 29 or more days after last dose of final study medication.
  4. Abbreviations: AE Adverse event, MedDRA Medical Dictionary for Regulatory Activities, GI Gastrointestinal, NSAID Nonsteroidal anti-inflammatory drug.