2.7. Adverse Events
death, disability/incapacity
ADVERSE EVENT, DISEASE, ADVERSE EVENT
Adverse events (AE) were recorded at each visit. We defined AE as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with ingestion of the foods. A serious adverse event (SAE) was defined as any untoward medical occurrence that results in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability/incapacity. An AE that was easily tolerated by the participant, causing minimal discomfort, and not interfering with everyday activities was classified as mild. An AE that was sufficiently discomforting to interfere with normal everyday activities was classified as moderate, and one that prevented normal everyday activities was classified as severe. Adverse events were evaluated through open-ended and non-leading verbal questioning of the participant. Based on signs, symptoms, and clinical information, a diagnosis was reached.