TABLE 4.
Adverse events (AE) by feeding group and time period (SAF population).
| Formula-fed (n = 105) |
Breastfed (n = 86) |
|||||
| 0 to ≤4 months | >4 to 12 months | 0 to 12 months | 0 to ≤4 months | >4 to 12 months | 0 to 12 months | |
| Subjects with at least one AE | 10 (9.5%) | 97 (92.4%) | 97 (92.4%) | 10 (11.6%) | 67 (77.9%) | 67 (77.9%) |
| Seriousness | ||||||
| No | 10 (9.5%) | 96 (91.4%) | 97 (92.4%) | 10 (11.6%) | 67 (77.9%) | 67 (77.9%) |
| Yes | 0 (0%) | 15 (14.3%) | 15 (14.3%) | 0 (0%) | 11 (12.8%) | 11 (12.8%) |
| Relationship to product | ||||||
| Unrelated | 9 (8.6%) | 80 (76.2%) | 80 (76.2%) | 10 (11.6%) | 67 (77.9%) | 67 (77.9%) |
| Unlikely | 1 (1.0%) | 13 (12.4%) | 13 (12.4%) | 0 (0%) | 1 (1.2%) | 1 (1.2%) |
| Probable | 0 (0%) | 33 (31.4%) | 33 (31.4%) | 0 (0%) | 2 (2.3%) | 2 (2.3%) |
| Related | 0 (0%) | 4 (3.8%) | 4 (3.8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Severity | ||||||
| Mild | 9 (8.6%) | 84 (80.0%) | 84 (80.0%) | 10 (11.6%) | 62 (72.1%) | 63 (73.3%) |
| Moderate | 1 (1.0%) | 46 (43.8%) | 46 (43.8%) | 1 (1.2%) | 25 (29.1%) | 25 (29.1%) |
| Severe | – | 4 (3.8%) | 4 (3.8%) | – | 3 (3.5%) | 3 (3.5%) |
| Caused study discontinuation | ||||||
| No | 10 (9.5%) | 94 (89.5%) | 94 (89.5%) | 10 (11.6%) | 67 (77.9%) | 67 (77.9%) |
| Yes | 0 (0%) | 8 (7.6%) | 8 (7.6%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Subjects with at least one allergy-related AE* | 0 (0%) | 17 (16.2%) | 17 (16.2%) | 2 (2.3%) | 14 (16.3%) | 16 (18.6%) |
*Including milk allergy, cow’s milk intolerance, lactose intolerance, eczema, atopic dermatitis, dry skin, seborrheic dermatitis, dermatitis, urticaria, and skin reaction. Percentages are computed with respect to the number of subjects per feeding group in the Safety Analysis (SAF) population.