Table 3.

Number (%) of patients with the most commonly reported adverse events (AE) (≥ 5% in at least one treatment group) during the treatment period in the safety analysis set.

System Organ ClassPlacebo, n = 80Naproxcinod 750 mg qd, n = 108Naproxcinod 750 mg bid, n = 116Naproxcinod 1125 mg bid, n = 124Rofecoxib 25 mg qd, n = 115
Gastrointestinal disorders28 (35)40 (37)52 (45)59 (48)40 (35)
  Dyspepsia7 (9)11 (10)22 (19)9 (7)12 (10)
  Nausea6 (8)11 (10)11 (9)15 (12)12 (10)
  Diarrhea (not specified)6 (8)6 (6)9 (8)9 (7)10 (9)
  Loose stools6 (8)3 (3)2 (2)2 (2)2 (2)
  Constipation5 (6)8 (7)2 (2)9 (7)3 (3)
  Flatulence2 (3)5 (5)5 (4)8 (6)4 (3)
  Abdominal pain upper1 (1)2 (2)3 (3)7 (6)4 (3)
  Abdominal pain not specified2 (3)2 (2)1 (1)6 (5)1 (1)
  Gastroesophageal reflux disease05 (5)2 (2)1 (1)2 (2)
Nervous system disorders34 (43)47 (44)36 (31)53 (43)43 (37)
  Headache28 (35)37 (34)29 (25)45 (36)36 (31)
  Dizziness6 (8)14 (13)14 (12)14 (11)9 (8)
Musculoskeletal and connective tissue disorders20 (25)21 (19)16 (14)27 (22)27 (23)
  Back pain7 (9)5 (5)5 (4)13 (10)11 (10)
  Arthralgia2 (3)8 (7)4 (3)7 (6)7 (6)
  Pain in extremity4 (5)5 (5)2 (2)2 (2)8 (7)
  Neck pain4 (5)4 (4)1 (1)2 (2)2 (2)
Infections and infestations13 (16)15 (14)24 (21)22 (18)25 (22)
  Nasopharyngitis6 (8)6 (6)8 (7)6 (5)11 (10)
Respiratory, thoracic, mediastinal disorders5 (6)12 (11)7 (6)10 (8)8 (7)
  Pharyngolaryngeal pain1 (1)6 (6)2 (2)5 (4)1 (1)