ADVERSE EVENTS (AE) (make multiple copies of this page if necessary) Any AEs? What is the AE term? AE number No Yes AEYN NOT SUBMITTED AETERM AESPID Ongoing? AEONGO |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| Start date/time End date/time MHENRTPT/MHENRF AESTDAT AESTDTC AESTTIM AESTDTC AEENDAT AEENDTC AEENTIM AEENDTC Toxicity grade Mild Moderate Severe Life threatening Fatal8181 AETOXGRV AETOXGRV4_1 AETOXGRV4_2 AETOXGRV4_3 AETOXGRV4_4 AETOXGRV4_5 Outcome Recovered/ Recovering/ Recovering/ Not recovered/ Fatal Unknown Resolved Not resolved Resolving with sequelae Resolving AEOUT Study treatment AE Relationship to treatment related give IP Not related Unlikely related Possibly related Probably related Definitely related AEREL Action taken with study treatment If other, specify Drug withdrawn Dose reduced Dose not changed Unknown NA Other AEACN Other action taken Describe other action No Yes taken AEACNOTH Is the AE serious Is this a special Yes No Yes No Was the AE expected? Yes No interest AE? AESER Give short description of the AE SERIOUS ADVERSE EVENTS – REPEAT AS REQUIRED
ADVERSE EVENTS (AE) (make multiple copies of this page if necessary) Any AEs? AEYN NOT SUBMITTED Yes No What is the AE term? AETERM AE number AESPID Start date/time |__|__|-|__|__|__|-|__|__|__|__| AESTDAT AESTDTC |__|__|:|__|__| AESTTIM AESTDTC End date/time |__|__|-|__|__|__|-|__|__|__|__| AEENDAT AEENDTC |__|__|:|__|__| AEENTIM AEENDTC Ongoing? AEONGO MHENRTPT/MHENRF Toxicity grade AETOXGRV Mild AETOXGRV4_1 Moderate AETOXGRV4_2 Severe AETOXGRV4_3 Life threatening AETOXGRV4_4 Fatal8181 AETOXGRV4_5 Outcome AEOUT Recovered/ Resolved Recovering/ Resolving with sequelae Recovering/ Resolving Not recovered/ Not resolved Fatal Unknown Relationship to treatment AEREL Not related Unlikely related Possibly related Probably related Definitely related Study treatment AE related give IP Action taken with study treatment AEACN Drug withdrawn Dose reduced Dose not changed Unknown NA Other If other, specify Other action taken AEACNOTH Yes No Describe other action taken Is the AE serious AESER Yes No Is this a special interest AE? Yes No Was the AE expected? Yes No Give short description of the AE SERIOUS ADVERSE EVENTS – REPEAT AS REQUIRED