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

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

Variable/event type/AE^a	nsNSAID (n = 225^b)	Celecoxib (n = 68^b)	Off NSAID^c(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)

^aPatients are counted only once in each AE of interest category, and only once in each event type category.
^bPatients will 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, CI Confidence interval GI Gastrointestinal, NSAID Nonsteroidal anti-inflammatory drug.

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