Table 4.
Adverse Events, n (%) | GS-9450 1 mg (n = 26) | 5 mg (n = 26) | 10 mg (n = 24) | 40 mg (n = 25) | Placebo (n = 23) |
---|---|---|---|---|---|
No. of subjects with at least one AE | 20 (77) | 22 (85) | 18 (75) | 20 (80) | 13 (57) |
Total no. of events | 62 | 64 | 67 | 60 | 48 |
Gastrointestinal disorders | |||||
Diarrhea | 2 (8) | 6 (23) | 6 (25) | 5 (20) | 2 (9) |
Nausea | 3 (12) | 1 (4) | 3 (13) | 3 (12) | 1 (4) |
Abdominal pain upper | 1 (4) | 1 (4) | 4 (17) | 1 (4) | 0 |
Abdominal pain | 1 (4) | 2 (8) | 1 (4) | 1 (4) | 1 (4) |
Dyspepsia | 2 (8) | 2 (8) | 1 (4) | 1 (4) | 0 |
Constipation | 2 (8) | 0 | 0 | 2 (8) | 1 (4) |
Dry mouth | 1 (4) | 0 | 2 (8) | 1 (4) | 0 |
Gastroesophageal reflux disease | 0 | 0 | 0 | 3 (12) | 1 (4) |
General disorders and administration site conditions | |||||
Fatigue | 6 (23) | 5 (19) | 2 (8) | 2 (8) | 5 (22) |
Asthenia | 1 (4) | 1 (4) | 1 (4) | 0 | 1 (4) |
Infections and infestations | |||||
Nasopharyngitis | 2 (8) | 0 | 0 | 2 (8) | 1 (4) |
Musculoskeletal and connective tissue disorders | |||||
Arthralgia | 1 (4) | 3 (12) | 1 (4) | 3 (12) | 0 |
Back pain | 1 (4) | 2 (8) | 0 | 1 (4) | 2 (9) |
Pain in extremity | 1 (4) | 0 | 1 (4) | 2 (8) | 0 |
Nervous system disorders | |||||
Headache | 4 (15) | 7 (27) | 4 (17) | 4 (16) | 5 (22) |
Dizziness | 2 (8) | 0 | 0 | 2 (8) | 1 (4) |
Somnolence | 1 (4) | 2 (8) | 0 | 0 | 0 |