ࡱ > E G D { ` bjbjBrBr 7* G $ $ ~ ~ ~ ~ ~ 8 $ T | B ^ ^ ^ ^ $ 2 ! | ! ~ ! ~ ~ ^ ^ 4 6 d ~ ^ ~ ^ ; ^ g9< $ F L 0 | , `" j D `" ; `" ~ ; ! ! d | `" $ D : STUDY NAMESite Number:
Pt_ID:
______________________
______________________
Has the participant had any Adverse Events during this study? FORMCHECKBOX Yes FORMCHECKBOX No (If yes, please list all Adverse Events below)
SeverityStudy Intervention RelationshipAction Taken Regarding Study InterventionOutcome of AEExpectedSerious1 = Mild
2 = Moderate
3 = Severe
1 = Definitely related
2 = Possibly related
3 = Not related
1 = None
2 = Discontinued permanently
3 = Discontinued temporarily
4 = Reduced Dose
5 = Increased Dose
6 = Delayed Dose1 = Resolved, No Sequel
2 = AE still present- no treatment
3 = AE still present-being treated
4 = Residual effects present-not treated
5 = Residual effects present- treated
6 = Death
7 = Unknown1 = Yes
2 = No1 = Yes
2 = No
(If yes, complete SAE form)
Adverse EventStart DateStop DateSeverityRelationship to Study TreatmentAction Taken
Outcome
of AEExpected?Serious Adverse Event?Initials
1.
2.3.
Adverse Event Form
Adverse Event Form Version 1.0
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