Adverse events (AE)
ADVERSE EVENTS, EVENTS, ADVERSE EVENT
ICD-10 codes will be used for all reported adverse events. Serious adverse events as identified by Good Clinical Practice §3 are described in terms of relatedness to treatment (yes/no) and whether the adverse event was expected (yes/no) [Death;Threat to life;Requirement for hospitalization or extension of current hospitalization;Persistent disability or incapacity;Medically relevant events (e.g., allergy).The number of treatment-related adverse events is reported divided by their relationship to treatment (“doubtful,” “possible,” “probably,” and “certain”).