TABLE 5.
Number and percentage of subjects with at least 1 serious adverse event presented by preferred term in the all subjects treated population
| n (%) | scGOS/lcFOS (n = 98) | scGOS/lcFOS +15% FERM (n = 110) | scGOS/lcFOS +50% FERM (n = 106) | 50% FERM (n = 102) |
| Allergy | 1 (0.9%) | |||
| Fever | 1 (1.0%) | 1 (0.9%) | 1 (1.0%) | |
| Pyloric stenosis | 1 (1.0%) | 1 (0.9%) | ||
| Abdominal pain | 1 (1.0%) | |||
| Gastroesophageal reflux | 1 (0.9%) | 1 (1.0%) | ||
| Vomiting | 2 (2.0%) | |||
| Fracture | 1 (1.0%) | |||
| Urinary tract infection | 1 (0.9%) | 1 (1.0%) | ||
| Apnoea | 1 (1.0%) | |||
| Bronchitis | 1 (0.9%) | 1 (0.9%) | ||
| Pneumonia | 1 (0.9%) | 1 (0.9%) | 1 (1.0%) | |
| Upper respiratory tract infection | 2 (2.0%) | |||
| Surgery | 1 (1.0%) | |||
| Varicella | 1 (1.0%) | |||
| Pyelonephritis | 3 (3.1%)* | |||
| Total | 13 (13.3%)† | 3 (2.7%)† | 7 (6.6%) | 4 (3.9%) |
15% FERM = infant formula consisting of 15% fermented infant formula; 50% FERM = infant formula consisting of 50% fermented infant formula; scGOS/lcFOS = short-chain galacto-oligosaccarides and long-chain fructo-oligosaccharides.
*Although officially recorded as 3 cases of pyelonephritis, detailed assessment of the medical records revealed an inconsistency for the use of this medical term, 1 case was a urinary tract infection and 1 case a direct result of a congenital anatomical anomaly causing vesicoureteral reflux.
†Values are significantly different, based on Fisher exact test (difference in number of subjects between groups).