3.4. Adverse event reporting
birth defects, deaths, disability or dysfunction
DISEASE
An AE will be defined as any unfavorable or unintended injury or sign, including abnormal laboratory values, that occurs in any subject, regardless of whether or not it is causally related to the study and protocol treatment. Exacerbations of preexisting disease during the protocol treatment period will be regarded as AEs. Data on all AEs occurring between the start of treatment and the last observation specified in the protocol will be recorded. Serious AEs will be defined as deaths, life-threatening AEs, AEs requiring hospitalization or prolonged hospitalization for treatment, permanent or marked disability or dysfunction, or birth defects in offspring.