ࡱ> `b_{ bjbjBrBr 8F  TTTTThhh8ThA@px(8$T???????$AcDv?T?TT4?   TT? ?  n<$><v = ?@0A@,=DVLD@$>DT$> ??pA@D : Protocol Title:Protocol Number: Site Number: Pt_ID: ______________________ ______________________ ______________________   SAE Onset Date: _______________ (dd/mm/yyyy) SAE Stop Date: __________(dd/mm/yyyy) Location of serious adverse event: _________________________________ Was this an unexpected adverse event? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Brief description of participant(s) with no personal identifiers: Sex: F  FORMCHECKBOX  M  FORMCHECKBOX  Age: ______ Brief description of the nature of the serious adverse event (attach description if more space needed): ___________________________________________________________________ ___________________________________________________________________ Category of the serious adverse event:  FORMCHECKBOX  death date __/___/___(dd/mmm/yyyy)  FORMCHECKBOX  congenital anomaly / birth defect  FORMCHECKBOX  life-threatening  FORMCHECKBOX  required intervention to prevent  FORMCHECKBOX  hospitalization-initial or prolonged permanent impairment  FORMCHECKBOX  disability / incapacity  FORMCHECKBOX  other:__________________ Intervention type:  FORMCHECKBOX  Medication or Nutritional Supplement: specify___________  FORMCHECKBOX  Device: Specify: ________________________  FORMCHECKBOX  Surgery: Specify: ________________________  FORMCHECKBOX  Behavioral/Life Style: Specify: _____________________ Relationship of event to intervention:  FORMCHECKBOX  Unrelated (clearly not related to the intervention)  FORMCHECKBOX  Possible (may be related to intervention)  FORMCHECKBOX  Definite (clearly related to intervention) Was study intervention discontinued due to event?  FORMCHECKBOX  Yes  FORMCHECKBOX  No What medications or other steps were taken to treat serious adverse event? 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