Table 2.
Summary of adverse drug reactions in each group
Placebo, n (%) | SK-1202, n (%) | |||
---|---|---|---|---|
13 g/day | 26 g/day | 39 g/day | ||
n = 62 | n = 63 | n = 63 | n = 62 | |
At least one ADR | 6 (9.7) | 2 (3.2) | 4 (6.3) | 13 (21.0) |
Gastrointestinal disordersa | ||||
Abdominal distension | 0 (0.0) | 1 (1.6) | 1 (1.6) | 2 (3.2) |
Abdominal pain | 2 (3.2) | 0 (0.0) | 1 (1.6) | 2 (3.2) |
Diarrhea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (9.7) |
Gastrointestinal sounds abnormal | 0 (0.0) | 0 (0.0) | 1 (1.6) | 2 (3.2) |
Investigationsa | ||||
Protein total decreased | 2 (3.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
ADR adverse drug reaction
aAdverse drug reactions reported by more than 2% of subjects in any group are shown