Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities.
An SAE is any untoward medical occurrence that at any dose, results in death in the view of the investigator places the participant at immediate risk of death requires inpatient hospitalization or prolongation of existing hospitalization results in persistent or significant disability/incapacity results in a congenital anomaly/birth defect is a medically important event. TEAE is any AE that start or worsen on or after the date of first dose of study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Why Should I Register and Submit Results?Īn AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
0 kommentar(er)
