2.8. Adverse Events
abnormal fluctuations
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT
Adverse events were investigated daily during the subjects’ consumption of the test foods by using a lifestyle questionnaire. In addition, laboratory values were also checked for abnormal fluctuations. If an adverse event was observed, the principal investigator took appropriate measures as necessary and categorized the adverse events into three levels: mild—not requiring any intervention and allowing the trial to continue; moderate—requiring some form of intervention; and severe—intolerable, thus necessitating the discontinuation of the trial. Furthermore, adverse events were classified into six levels: none, probably none, possible, probably present, present, and evaluation impossible. Only adverse events determined to have a causal relationship with the test food (excluding those classified as probably none or none) were considered as side effects.