2.3. Infant Gastrointestinal (GI) Tolerability and Health Examination
regurgitations and vomiting episodes, fever, Cancer
ADVERSE EVENTS, ADVERSE EVENT, CANCER
Infant GI tolerability and health was assessed by mothers on a daily basis from Day 1 until 3 months of age during test food supplementation period. Mothers were instructed to record the following information about their infants in daily logs: consumption of the amount of test foods, intake of any oral antibiotics or medicines, any symptoms including episodes of fever (≥38 °C), and hospital visits. For the 7 days before 1 week, 1 month, and 3 months of age, mothers recorded in daily logs the number of breast milk-fed and infant formula-fed infants, number of stools, stool consistency, duration and episodes of crying, number of regurgitations and vomiting episodes after feeding. Consistency of stool was assayed by mothers using a modified Amsterdam infant scale [A safety evaluation was conducted on all participants who consumed the study food once or more. Throughout the study period, all adverse events related to subjective and objective symptoms were recorded in the daily logs. The degree of symptoms and the causal relationship were evaluated according to the revised “National Cancer Institute, Common Terminology Standards for Adverse Events Version 4.0, Japanese Translation JCOG Version”.