Table 2.
Adverse events after multiple doses of LFF571 (part II)
| Adverse eventa | No. (%)c who received the following every 6 h: |
|||
|---|---|---|---|---|
| 25 mg LFF571 | 100 mg LFF571 | 200 mg LFF571 | Placebo | |
| Any | 5 (83.3) | 3 (50.0) | 5 (83.3) | 6 (85.7) |
| Gastrointestinal | ||||
| Pain or distension | 1 (16.7) | 0 | 3 (50) | 2 (28.6) |
| Constipation | 1 (16.7) | 0 | 0 | 0 |
| Diarrheab | 3 (50.0) | 1 (16.7) | 3 (50.0) | 6 (85.7) |
| Flatulence | 0 | 0 | 0 | 1 (14.3) |
| Nausea | 0 | 0 | 1 (16.7) | 1 (14.3) |
| Others that occurred in >1 subject | ||||
| Fatigue | 0 | 1 (16.7) | 1 (16.7) | 0 |
| Headache | 0 | 0 | 1 (16.7) | 1 (14.3) |
a
Adverse events were coded using Medical Dictionary for Regulatory Activities terminology. Shown are adverse-event preferred terms. Gastrointestinal pain or distension includes the preferred terms abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, dyspepsia, and gastrointestinal pain.
b
Only one instance of diarrhea is shown if a subject had more than one episode. This occurred in one subject who received 25 mg of LFF571 every 6 h (three separate diarrhea episodes) and in two subjects who received the placebo (two separate episodes of diarrhea in each subject).
c
There were six subjects in each LFF571 group and seven in the placebo group.