Table 5

 Study-emergent adverse events reported by treatment group for both periods combined* in PACES clinical trials.

CelecoxibAcetaminophenPlacebop Value†
*Values are the number (%) of patients reporting at least 1 event. Percentage are based on the number of patients exposed to the drug in either period; †p values are from a conditional logistic regression model with effects for period and treatment.
A. PACES-a
Patients who took drug (n)350300289
Any event100 (28.6)85 (28.3)76 (26.3)0.813
Serious events1 (0.3)3 (1.0)4 (1.4)0.999
Any gastrointestinal event42 (12.0)28 (9.3)26 (9.0)0.129
    Diarrhoea8 (2.3)14 (4.7)4 (1.4)0.999
    Dyspepsia10 (2.9)7 (2.3)3 (1.0)0.641
    Nausea7 (2.0)7 (2.3)5 (1.7)0.872
    Flatulence8 (2.3)4 (1.3)1 (0.3)0.232
Other
Upper respiratory tract infection16 (4.6)17 (5.7)9 (3.1)0.3620
Headache4 (1.1)11 (3.7)5 (1.7)0.872
B. PACES-b
Patients who took drug (n)373331273
Any event103 (27.6)87 (26.3)63 (23.1)0.423
Serious events2 (0.5)1 (0.3)1 (0.4)0.999
Any gastrointestinal event35 (9.4)30 (9.1)17 (6.2)0.500
    Diarrhoea6 (1.6)11 (3.3)4 (1.5)0.870
    Dyspepsia6 (1.6)6 (1.8)2 (0.7)0.999
    Nausea8 (2.1)4 (1.2)3 (1.1)0.329
    Flatulence3 (0.8)4 (1.2)1 (0.4)
Other
Upper respiratory tract infection7 (1.9)9 (2.7)2 (0.7)0.248
Headache7 (1.9)9 (2.7)7 (2.6)0.419