Table 5.
Frequency of AEs (% of all AEs in the respective treatment group)
| Total | Probi Defendum® | Placebo | p*# | |
|---|---|---|---|---|
| Total no. of AEs | 97 | 46 | 51 | |
| Gastrointestinal related AEs (%) | 61 (62.8) | 34 (73.9) | 27 (52.9) | 0.037 |
| Constipation | 5 (5.1) | 2 (4.3) | 3 (5.9) | NS |
| Diarrhoea | 5 (5.1) | 2 (4.3) | 3 (5.9) | NS |
| Flatulence | 2 (2.1) | 1 (2.8) | 1 (1.96) | NS |
| Loose stools | 6 (6.2) | 3 (6.5) | 3 (5.9) | NS |
| Stomach pain | 2 (2.1) | 2 (4.3) | 0 | NS |
| Gastroenteritis | 30 (30.9) | 15 (32.6) | 15 (29.4) | NS |
| Vomiting | 11 (11.3) | 9 (19.6) | 2 (3.9) | 0.092 |
| Non-gastrointestinal-related AEs (%) | 36 (37.1) | 12 (26.1) | 24 (47.0) | 0.037 |
| AEs possibly related to the treatment (%) | 8 (8.4) | 5 (10.9) | 3 (5.9) | NS |
*Fischer’s exact test
#Compared to the total nr of AEs reported in the same group