Table 12.
Cohort 1 | Cohort 2 | Cohort 3 | |||||
---|---|---|---|---|---|---|---|
Placebo n = 9 | 300 mg b.i.d. n = 9 | 600 mg b.i.d. n = 8 | 600 mg b.i.d. n = 9 | 900 mg b.i.d. n = 8 | 900 mg b.i.d. n = 9 | 1200 mg q.d. n = 9 | |
Number of subjects with >1 Adverse event* | 9 | 9 | 6 | 8 | 8 | 8 | 8 |
Abdominal pain | 2 | 1 | 1 | 2 | 1 | 0 | 2 |
Asthenia | 1 | 0 | 0 | 4 | 1 | 6 | 4 |
Headache | 3 | 2 | 1 | 3 | 5 | 3 | 2 |
Postural hypotension | 0 | 0 | 0 | 0 | 0 | 5 | 6 |
Dry mouth | 0 | 0 | 2 | 0 | 1 | 2 | 3 |
Flatulence | 1 | 2 | 0 | 1 | 0 | 1 | 1 |
Nausea | 1 | 2 | 2 | 4 | 3 | 4 | 2 |
Hyperlipidaemia | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
Dizziness | 2 | 2 | 2 | 6 | 7 | 3 | 3 |
Somnolence | 0 | 0 | 0 | 4 | 6 | 0 | 0 |
Cough increased | 1 | 1 | 0 | 1 | 2 | 0 | 0 |
Epistaxis | 0 | 0 | 0 | 2 | 4 | 0 | 1 |
Pharyngitis | 1 | 3 | 2 | 0 | 0 | 0 | 0 |
Rhinitis | 0 | 1 | 3 | 2 | 4 | 2 | 3 |
Rash | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
Abnormal vision | 0 | 0 | 1 | 2 | 3 | 3 | 0 |
Conjunctivitis† | 0 | 0 | 0 | 0 | 5 | 4 | 5 |
Eye pain | 1 | 0 | 0 | 1 | 2 | 1 | 1 |
Table shows adverse events that were reported by more than one subject in any treatment group.
The investigator term for all the cases of conjunctivitis was bloodshot eyes.