Table 2. Frequency of adverse events by group.
Group 1 | Group 2 | Group 3 | Group 4 | Naïve | Veteran | |
---|---|---|---|---|---|---|
Dose | 108 | 109 | 109 | 1010 | 109 | 109 |
Fasting | Overnight | 90 minutes | Overnight | 90 minutes | Overnight | Overnight |
N | 7 | 7 | 7 | 7 | 19 | 11 |
Abdominal cramps, n (%) | 5 (71.4) | 5 (71.4) | 5 (71.4) | 3 (42.9) | 13 (68.4) | 7 (63.6) |
Abdominal Pain, n (%) | 3 (42.9) | 4 (57.1) | 5 (71.4) | 5 (71.4) | 12 (63.2) | 7 (63.6) |
Abdominal Tenderness, n (%) | 0 (0.0) | 0 (0.0) | 2 (28.9) | 0 (0.0) | 9 (47.4) | 2 (18.2) |
Anorexia, n (%) | 4 (57.1) | 4 (57.1) | 5 (71.4) | 4 (57.1) | 14 (73.7) | 4 (36.4) |
Arthralgia, n (%) | 0 (0.0) | 1 (14.3) | 0 (0.0) | 1 (14.3) | 3 (15.8) | 1 (9.1) |
Bloating, n (%) | 5 (71.4) | 6 (85.7) | 5 (71.4) | 4 (57.1) | 11 (57.9) | 5 (45.5) |
Constipation, n (%) | 1 (14.3) | 1 (14.3) | 2 (28.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Fever, n (%) | 0 (0.0) | 0 (0.0) | 1 (14.3) | 0 (0.0) | 3 (15.8) | 1 (9.1) |
Flatulence, n (%) | 7 (100.0) | 6 (85.7) | 6 (85.7) | 4 (57.1) | 10 (52.6) | 7 (63.6) |
Generalized Myalgia, n (%) | 0 (0.0) | 1 (14.3) | 0 (0.0) | 1 (14.3) | 3 (15.8) | 2 (18.2) |
Headache, n (%) | 3 (42.9) | 4(57.1) | 3 (42.9) | 5 (71.4) | 10 (52.6) | 4 (36.4) |
Hyperactive Bowel Sounds, n (%) | 5 (71.4) | 2 (28.9) | 7 (100.0) | 3 (42.9) | 8 (42.1) | 3 (27.3) |