AE Adverse Serious Onset Date & Severity Related Expected Action Taken Outcome Final Outcome Initials # Event Time Date & Time (MM/DD/YY) Term Yes Mild Reasonable Yes None Resolved Resolved Not with No Moderate Reasonable No Stop Treatment Sequelae Severe Reduce Dose Stable Continuing/ Not Hold Dose Resolved Medication Death Hospitalization Yes Mild Reasonable Yes None Resolved Resolved Not with No Moderate Reasonable No Stop Treatment Sequelae Severe Reduce Dose Stable Continuing/ Not Hold Dose Resolved Other Medication Death Hospitalization Yes Mild Reasonable Yes None Resolved Resolved Not with No Moderate Reasonable No Stop Treatment Sequelae Severe Reduce Dose Stable Continuing/ Not Hold Dose Resolved Other Medication Death Hospitalization Yes Mild Reasonable Yes None Resolved Resolved Not with No Moderate Reasonable No Stop Treatment Sequelae Severe Reduce Dose Stable Continuing/ Not Hold Dose Resolved Other Medication Death Hospitalization Initials = Name and title
AE # Adverse Event Term Serious Onset Date & Time (MM/DD/YY) Severity Related Expected Action Taken Outcome Final Outcome Date & Time Initials Yes Mild Reasonable Yes None Resolved No Moderate Not Reasonable No Stop Treatment Resolved with Sequelae Severe Reduce Dose Stable Hold Dose Continuing/ Not Resolved Medication Death Hospitalization Yes Mild Reasonable Yes None Resolved No Moderate Not Reasonable No Stop Treatment Resolved with Sequelae Severe Reduce Dose Stable Hold Dose Continuing/ Not Resolved Other Medication Death Hospitalization Yes Mild Reasonable Yes None Resolved No Moderate Not Reasonable No Stop Treatment Resolved with Sequelae Severe Reduce Dose Stable Hold Dose Continuing/ Not Resolved Other Medication Death Hospitalization Yes Mild Reasonable Yes None Resolved No Moderate Not Reasonable No Stop Treatment Resolved with Sequelae Severe Reduce Dose Stable Hold Dose Continuing/ Not Resolved Other Medication Death Hospitalization Initials = Name and title