AE single Report Form Study Title: Site No. Local Investigator Adverse Event:__________________________________________________________________ Onset of AE: End of AE: I__I__I I__I__I. I__I__II__I__I__II__I__I I__I__I I__I__I. I__I__II__I__I__II__I__I hh mm dd MMM yy hh mm dd MMM yy Intensity of AE: Relation to study drug: (causality) certain □ mild (tolerable) □ moderate (interferes with daily activities) probably /likely □ □ severe (daily activities impossible) possible □ □ unlikely □ conditional/ unclassified □ unassessable/ unclassifiable □ unrelated □ Frequency: single episode intermittent continuous □ □ □ SAE No Yes If Yes, please complete SAE-Form □ □ Action taken? none study drug dosage adjusted □ □ non drug therapy study discontinued □ □ concomitant medication study drug discontinued □ □ Specify therapy / concomitant medication / Comments: Outcome: resolved without sequel unknown □ □ resolved with sequel others (specify): ______________________________ □ □ ongoing □ Date of record: ___________ Signature: _____________________________________
AE single Report Form Study Title: Site No. Local Investigator Adverse Event:__________________________________________________________________ Onset of AE: End of AE: I__I__I I__I__I. I__I__II__I__I__II__I__I I__I__I I__I__I. I__I__II__I__I__II__I__I hh mm dd MMM yy hh mm dd MMM yy Intensity of AE: □ mild (tolerable) □ moderate (interferes with daily activities) □ severe (daily activities impossible) Relation to study drug: (causality) □ certain □ probably /likely □ possible □ unlikely □ conditional/ unclassified □ unassessable/ unclassifiable □ unrelated Frequency: □ single episode □ intermittent □ continuous SAE □ No □ Yes If Yes, please complete SAE-Form Action taken? □ none □ study drug dosage adjusted □ non drug therapy □ study discontinued □ concomitant medication □ study drug discontinued Specify therapy / concomitant medication / Comments: Outcome: □ resolved without sequel □ unknown □ resolved with sequel □ others (specify): ______________________________ □ ongoing Date of record: ___________ Signature: _____________________________________
ae-single-report-form-v3.0-okt-17_20171019141842.docx