ADVERSE EVENTS (AE) (make multiple copies of this page if necessary) Any AEs? What is the AE term? AE number No Yes AEYN AETERM AESPID Ongoing? |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| AEONGO AESTDAT AESTDTC AEENDAT AEENDTC MHENRTPT/MHENRF Start date/time End date/time |__|__|:|__|__| |__|__|:|__|__| AESTTIM AESTDTC AEENTIM AEENDTC Toxicity grade Mild Moderate Severe Life threatening Fatal7979 AETOXGRV AETOXGRV4_1 AETOXGRV4_2 AETOXGRV4_3 AETOXGRV4_4 AETOXGRV4_5 Recovering/ Outcome Recovered/ Recovering/ Not recovered/ Resolving with Fatal Unknown Resolved Resolving Not resolved sequelae If AE related to study treatment, Relationship to study Definitely specify IP Not related Unlikely related Possibly related Probably related treatment AEREL related If other, specify Action taken with study AEACNOTH Drug withdrawn Dose reduced Dose not changed Unknown NA Other treatment AEACN Other action taken No Describe other action taken Yes AEACNOTH Is this a special Is the AE serious Was the AE expected? Yes No Yes No Yes No interest AE? AESER AEEXP AESI Give description of the AE SERIOUS ADVERSE EVENTS – REPEAT AS REQUIRED
ADVERSE EVENTS (AE) (make multiple copies of this page if necessary) Any AEs? AEYN Yes No What is the AE term? AETERM AE number AESPID Start date/time |__|__|-|__|__|__|-|__|__|__|__| AESTDAT AESTDTC End date/time |__|__|-|__|__|__|-|__|__|__|__| AEENDAT AEENDTC Ongoing? AEONGO MHENRTPT/MHENRF |__|__|:|__|__| AESTTIM AESTDTC |__|__|:|__|__| AEENTIM AEENDTC Toxicity grade AETOXGRV Mild AETOXGRV4_1 Moderate AETOXGRV4_2 Severe AETOXGRV4_3 Life threatening AETOXGRV4_4 Fatal7979 AETOXGRV4_5 Outcome Recovered/ Resolved Recovering/ Resolving with sequelae Recovering/ Resolving Not recovered/ Not resolved Fatal Unknown Relationship to study treatment AEREL Not related Unlikely related Possibly related Probably related Definitely related If AE related to study treatment, specify IP Action taken with study treatment AEACN Drug withdrawn Dose reduced Dose not changed Unknown NA Other If other, specify AEACNOTH Other action taken AEACNOTH Yes No Describe other action taken Is the AE serious AESER Yes No Is this a special interest AE? AESI Yes No Was the AE expected? AEEXP Yes No Give description of the AE SERIOUS ADVERSE EVENTS – REPEAT AS REQUIRED
wwarn-malaria-case-record-form-crf-v2_09apr2018.docx