Adverse Event Form STUDY NAME This form is cumulative and captures adverse Site Name:___________________________ events of a single participant throughout the Pt_ID:_________________________ study. Action Taken Serious Study Intervention Regarding Study Adverse Severity Relationship Intervention Outcome of AE Expected Event (SAE) 1 = Mild 0 = Not related 0 = None 1 = Resolved 1 = Yes 1 = Yes 2 = Moderate 1 = Unlikely related 1 = Dose modification 2 = Recovered with 2 = No 2 = No 3 = Severe 2 = Possibly related 2 = Medical Intervention minor sequelae (if yes, 4 = 3 = Probably related 3 = Hospitalization 3 = Recovered with complete 4 = Definitely related 4 = Intervention major sequelae SAE form) discontinued 4 = Ongoing/Continuing 5 = Other treatment 5 = Condition worsening 6 = Death 7 = Unknown At end of study only: Check this box if participant had no adverse events None Start Stop Action Outcome Adverse Event Date Date Severity Relationship Taken of AE Expected? SAE?
Adverse Event Form STUDY NAME Site Name:___________________________ Pt_ID:_________________________ This form is cumulative and captures adverse events of a single participant throughout the study. Severity Study Intervention Relationship Action Taken Regarding Study Intervention Outcome of AE Expected Serious Adverse Event (SAE) 1 = Mild 2 = Moderate 3 = Severe 4 = 0 = Not related 1 = Unlikely related 2 = Possibly related 3 = Probably related 4 = Definitely related 0 = None 1 = Dose modification 2 = Medical Intervention 3 = Hospitalization 4 = Intervention discontinued 5 = Other 1 = Resolved 2 = Recovered with minor sequelae 3 = Recovered with major sequelae 4 = Ongoing/Continuing treatment 5 = Condition worsening 6 = Death 7 = Unknown 1 = Yes 2 = No 1 = Yes 2 = No (if yes, complete SAE form) At end of study only: Check this box if participant had no adverse events None Adverse Event Start Date Stop Date Severity Relationship Action Taken Outcome of AE Expected? SAE?