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Table 2 AEs of special interest and composite gastrointestinal AEs by current treatment group (safety analysis set)

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

Variable/event type/AEa nsNSAID (n = 225b) Celecoxib (n = 68b) Off NSAIDc(n = 79)
Incidence, n (%)    
Patients with at least 1 AE of special interest 2 (0.9) 0 2 (2.5)
GI 0 0 1 (1.3)
GI ulcer 0 0 0
Complications of GI ulcer 0 0 1 (1.3)
Cardiovascular/cardiorenal 2 (0.9) 0 1 (1.3)
Thromboembolic events 0 0 0
New-onset or worsening hypertension 2 (0.9) 0 1 (1.3)
Patients with at least 1 GI composite event 73 (32.4) 23 (33.8) 17 (21.5)
Abdominal pain 39 (17.3) 12 (17.6) 6 (7.6)
Nausea/vomiting 31 (13.8) 13 (19.1) 8 (10.1)
All other GI 44 (19.6) 11 (16.2) 11 (13.9)
Incidence rate (per 100 person-years), (95% CI)    
Total person-years 267.6 68.0 74.6
Incidence rate of events of special interest 0.7 (0–1.8) 0 2.7 (0–6.4)
GI 0 0 1.3 (0–4.0)
Gl ulcer 0 0 0
Complications of GI ulcer 0 0 1.3 (0–4.0)
Cardiovascular/cardiorenal 0.7 (0–1.8) 0 1.3 (0–4.0)
Thromboembolic events 0 0 0
New-onset or worsening hypertension 0.7 (0–1.8) 0 1.3 (0–4.0)
Incidence rate of GI composite events 27.3 (21.0–33.5) 33.8 (20.0–47.6) 22.8 (12.0–33.6)
Abdominal pain 14.6 (10.0–19.1) 17.6 (7.7–27.6) 8.0 (1.6–14.5)
Nausea/vomiting 11.6 (7.5–15.7) 19.1 (8.7–29.5) 10.7 (3.3–18.2)
All other GI 16.4 (11.6–21.3) 16.2 (6.6–25.7) 14.7 (6.0–23.5)
  1. aPatients are counted only once in each AE of interest category, and only once in each event type category.
  2. bPatients will 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, CI Confidence interval GI Gastrointestinal, NSAID Nonsteroidal anti-inflammatory drug.
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