Table 5.
Number of infants in the safety set (n = 311) with the most abundant adverse events reported during the study period (V1–V6) categorized by MedDRA v23.1. Primary SOC. Please see Table S3 for full overview of all AEs.
| 5HMO-Mix | IF | BM | 5HMO-Mix vs. IF | 5HMO-Mix vs. BM |
IF vs. BM | |
|---|---|---|---|---|---|---|
| n | n | n | p-Value | p-Value | p-Value | |
| Gastrointestinal disorders | 64 | 58 | 40 | 0.3975 | 0.0008 | 0.0180 |
| Infections and infestations | 32 | 28 | 34 | 0.5426 | 0.8817 | 0.4486 |
| Skin and subcutaneous tissue disorders | 14 | 21 | 7 | 0.2660 | 0.1129 | 0.0074 |
| Respiratory, thoracic, and mediastinal disorders | 10 | 10 | 7 | 1.0000 | 0.4603 | 0.6140 |
| General disorders and administration site conditions | 6 | 8 | 15 | 0.7831 | 0.0635 | 0.1838 |
| Metabolism and nutrition disorders | 5 | 1 | 3 | 0.1187 | 0.4981 | 0.6214 |
n = number of subjects.