Real-world evidence study on tolerance and growth in infants fed an infant formula with two human milk oligosaccharides vs mixed fed and exclusively breastfed infants

Molecular and Cellular Pediatrics

Table 4 Overview of adverse events, by feeding group, in the safety data set (n = 117)

	BF (N = 44)	MF (N = 22)	FF (N = 51)
Occurrence	11 (25.0%) [18]	6 (27.3%) [10]	29 (56.9%) [41]
Severity
Mild^b	11 (25.0%) [18]	6 (27.3%) [9]	22 (43.1%) [32]
Moderate^c	0 (0.0%) [0]	1 (4.6%) [1]	8 (15.7%) [9]
Caused study discontinuation
Yes	0 (0.0%) [0]	0 (0.0%) [0]	4 (7.8%) [4]^a
No	11 (25.0%) [18]	6 (27.3%) [10]	27 (52.3%) [37]

Data shown as N (%) [m]
N number of subjects with at least one AE, m total number of adverse events, BF exclusively breastfed group, MF mixed-fed group, FF formula-fed group (exclusively)
^aThese four infants in FF experienced potentially product-related AEs including instances of lactose intolerance, hard feces, vomiting, and diarrhea
^bMild AEs, negative clinical sign/situation which requires no intervention
^cModerate AEs, negative clinical sign/situation which requires an intervention but without relevant or long-lasting limitations for the subject