Fatal AESDTH If hospitalization/ prolonged Life threatening AESLIFE hospitalization give admission date Requires or prolongs hospitalization AESHOSP HOSTDAT where HOTERM = HOSPITALIZATION SAE Results in permanent or significant disability/incapacity AESDISAB Classification Congenital anomaly/birth defect AESCONG If hospitalization/prolonged 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 Taken daily Medication prior to Units Route of administration Start date End date Indication CMSTDAT CMSTDTC CMENDAT CMENDTC dose study? Start time End time CMTRT CMDOSU CMROUTE CMTIM CMSTDTC CMENTIM CMENDTC CMINDC CMDOSTOT CMPRIOR mg mL IM PO IV |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| Yes |__|__|:|__|__| |__|__|:|__|__| tsp TABLET SC TOP PR Ongoing? CMONGO No CMENRTPT/CMENRF mg mL PO IV IM |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| Yes |__|__|:|__|__| |__|__|:|__|__|
SAE Classification Fatal AESDTH Life threatening AESLIFE Requires or prolongs hospitalization AESHOSP Results in permanent or significant disability/incapacity AESDISAB Congenital anomaly/birth 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 Yes No Medication CMTRT 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 End time CMENTIM 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 |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| |__|__|:|__|__|
wwarn-malaria-case-record-form-crf-v2_09apr2018.docx