Fatal If hospitalization/ prolonged AESDTH Life threatening hospitalization give admission date AESLIFE Requires or prolongs hospitalization AESHOSP HOSTDAT where HOTERM = HOSPITALIZATION SAE Results in permanent or significant disability/incapacity AESDISAB Classification Congenital defect If hospitalization/prolonged AESCONG Medically significant |__|__|-|__|__|__|-|__|__|__|__| AESMIE hospitalization give discharge date Describe medically significant condition: HOENDAT where HOTERM = HOSPITALIZATION ________________________________________ Give short description of the SAE CONCOMITANT MEDICATION CM Was any medication given? Yes No CMYN NOT SUBMITTED Taken Total daily Medication prior to Units Route of administration Start date Indication CMSTDAT CMSTDTC dose End date CMENDAT CMENDTC study? Start time CMDOSU CMROUTE CMTIM CMSTDTC CMINDC CMDOSTOT CMPRIOR mg mL PO IV IM Yes |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| tsp TABLET SC TOP PR Ongoing? CMONGO No |__|__|:|__|__| CMENRTPT/CMENRF mg mL PO IV IM Yes |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| tsp TABLET SC TOP PR Ongoing? CMONGO No |__|__|:|__|__| CMENRTPT/CMENRF
SAE Classification Fatal AESDTH Life threatening AESLIFE Requires or prolongs hospitalization AESHOSP Results in permanent or significant disability/incapacity AESDISAB Congenital defect AESCONG Medically significant AESMIE Describe medically significant condition: ________________________________________ If hospitalization/ prolonged hospitalization give admission date HOSTDAT where HOTERM = HOSPITALIZATION If hospitalization/prolonged hospitalization give discharge date HOENDAT where HOTERM = HOSPITALIZATION |__|__|-|__|__|__|-|__|__|__|__| Give short description of the SAE CONCOMITANT MEDICATION CM Was any medication given? CMYN NOT SUBMITTED Yes No Medication Total daily dose CMDOSTOT Taken prior to study? CMPRIOR Units CMDOSU Route of administration CMROUTE Start date CMSTDAT CMSTDTC Start time CMTIM CMSTDTC End date CMENDAT CMENDTC Indication CMINDC Yes mg mL PO IV IM |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| No tsp TABLET SC TOP PR |__|__|:|__|__| Ongoing? CMONGO CMENRTPT/CMENRF Yes mg mL PO IV IM |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| No tsp TABLET SC TOP PR |__|__|:|__|__| Ongoing? CMONGO CMENRTPT/CMENRF