Table 5 Adverse events in full analysis data set (FAS)
Overall | Bif195 | Placebo | *p-value | ||
|---|---|---|---|---|---|
E | (n = 33) | (n = 16) | (n = 17) | ||
All adverse events | 16 | 11 (33) | 5 (31) | 6 (35) | |
Abdominal pain | 2 | 2 (6) | 1 (6) | 1 (6) | 1.00 |
Diarrhoea | 3 | 3 (9) | 1 (6) | 2 (12) | 1.00 |
Constipation | 2 | 2 (6) | 1 (6) | 1 (6) | 1.00 |
Bloating and/or flatulence | 3 | 3 (9) | 0 | 3 (18) | 0.23 |
Nausea | 2 | 2 (6) | 2 (13) | 0 | 0.23 |
Borborygmi | 1 | 1 (3) | 0 | 1 (6) | 1.00 |
Skin rash | 1 | 1 (3) | 0 | 1 (6) | 1.00 |
Other | 2 | 2 (6) | 1 (6) | 1 (6) | 1.00 |