Sae__.mp4 Official

: Requires inpatient admission or prolongs an existing stay.

: A birth defect resulting from exposure to the study product. Sae__.mp4

An event is classified as "serious" if it meets one or more of the following criteria: : Regardless of the perceived cause. : Requires inpatient admission or prolongs an existing stay

: Required to prevent one of the outcomes listed above. Required Reporting Information SAE Reporting and the IRB: Adverse Events in Drug Studies Sae__.mp4