Table 2.
Adverse events
| AE, No. (%) of Patients | Placebo BID (N = 206) | Lubiprostone 24 mcg BID (N = 208) | P value* |
|---|---|---|---|
| At least 1 AE | 112 (54.4) | 132 (63.5) | 0.072 |
| AEs in ≥5% of either treatment arm | |||
| Nausea | 12 (5.8) | 35 (16.8) | <0.001 |
| Diarrhea | 6 (2.9) | 20 (9.6) | 0.007 |
| Abdominal distention | 5 (2.4) | 17 (8.2) | 0.014 |
| At least 1 treatment-related AE | 48 (23.3) | 76 (36.5) | 0.004 |
| Treatment-related AEs in ≥2% of either treatment arm | |||
| Nausea | 11 (5.3) | 32 (15.4) | 0.001 |
| Abdominal distention | 5 (2.4) | 16 (7.7) | 0.023 |
| Diarrhea | 3 (1.5) | 15 (7.2) | 0.006 |
| Flatulence | 5 (2.4) | 8 (3.8) | 0.575 |
| Vomiting | 4 (1.9) | 5 (2.4) | 1.000 |
| Upper abdominal pain | 7 (3.4) | 1 (0.5) | 0.037 |
| Abdominal pain | 1 (0.5) | 8 (3.8) | 0.037 |
| Headache | 4 (1.9) | 7 (3.4) | 0.543 |
| Gamma-glutamyltransferase increased | 5 (2.4) | 2 (1.0) | 0.283 |
AE = adverse event; BID = twice daily.
*
P values are from Fisher's exact test.