TABLE 2.
Preferred term, MedDRA dictionary 19.1 | Lubiprostone 12 mcg BID (n = 56), no. (%) | Lubiprostone 24 mcg BID (n = 31), no. (%) | Total (N = 87), no. (%) |
Diarrhea | 3 (5.4) | 3 (9.7) | 6 (6.9) |
Nausea | 4 (7.1) | 0 (0.0) | 4 (4.6) |
Abdominal pain upper | 1 (1.8) | 2 (6.5) | 3 (3.4) |
Abdominal pain | 1 (1.8) | 1 (3.2) | 2 (2.3) |
Dyspepsia | 2 (3.6) | 0 (0.0) | 2 (2.3) |
Chest pain | 2 (3.6) | 0 (0.0) | 2 (2.3) |
Blood uric acid decreased | 2 (3.6) | 0 (0.0) | 2 (2.3) |
Decreased appetite | 1 (1.8) | 1 (3.2) | 2 (2.3) |
Headache | 3 (5.4) | 1 (3.2) | 4 (4.6) |
BID = twice daily; MedDRA = Medical Dictionary for Regulatory Activities; n = subgroup of total population; N = total population.