Question

Serious Adverse Event (SAE) is defined as any untoward medical occurrence in a clinical trial participant that: (select all that apply)

Results in death

Is life-threatening

Requires inpatient hospitalization or prolongation of existing hospitalization

Is a congenital anomaly/birth defect

Answer 1

All of the above.

Those four items are standard SAE criteria (death; life‑threatening; inpatient hospitalization or prolongation of hospitalization; congenital anomaly/birth defect). Other SAE criteria also include persistent/significant disability or incapacity and other medically important events that may jeopardize the participant or require intervention to prevent a serious outcome (per ICH-GCP/ICH E2A definitions).