3.8. Adverse Events
perianal abscess, Gastrointestinal adverse, fever, stomach pain, flatulence, CMPA, vomiting, watery, cough, airway infections, nasal congestion, bronchiolitis, runny nose or fever, breathing difficulties, pylorus stenosis
ADVERSE EVENT, PERIANAL ABSCESS, BRONCHIOLITIS
Adverse events (AE) were reported in 182 FF infants (SF = 64, α-lac-EW = 58 and CGMP-RW = 60) and in 57 BF infants, with no significant differences among the groups, the majority relating to fever or mild airway infections (defined as ≥ 2 of the following symptoms; cough, breathing difficulties, nasal congestion, runny nose or fever). Hospitalization was reported in six infants, three in the CGMP-RW group; RSV bronchiolitis or fever of unknown origin, and three in the SF group; pylorus stenosis, perianal abscess (both underwent surgical intervention), and one apneic episode. Gastrointestinal adverse events (watery or hard stools, stomach pain, vomiting or flatulence), including those diagnosed with CMPA, that resulted in discontinuation of the study or switching to another formula were reported in 26 infants (11 in SF, 4 in α-lac-EW and 11 in CGMP-RW group), but with no significant difference among the FF groups (