SAE / Serious Participants Age / Sex Country Description Description Date of Date of Outcome Comments, SADR / adverse ID (F=female, and site in of event/ of treatment (e.g. if relevant SUSAR event/ M=male) which reaction intervention (start and resolved, (e.g. reaction participant (dosage, stop) causality No. is/was schedule, improved, assessment, enrolled route, if sequel, relationship) (for applicable) unknown) multicentre, international trials) [type] [no.] [no.] [age] / [country, [as [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] [sex] site] recorded] [type] [no.] [no.] [age] / [country, [as [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] [sex] site] recorded] [type] [no.] [no.] [age] / [country, [as [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] [sex] site] recorded] [type] [no.] [no.] [age] / [country, [as [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] [sex] site] recorded] Signature and approval Place / date Name and signature of sponsor-investigator [place and date] Appendix SUSAR reports If applicable, please list the reports including reference number [no. or n/a] [free text]
SAE / SADR / SUSAR Serious adverse event/ reaction No. Participants ID Age / Sex (F=female, M=male) Country and site in which participant is/was enrolled (for multicentre, international trials) Description of event/ reaction Description of intervention (dosage, schedule, route, if applicable) Date of Date of treatment (start and stop) Outcome (e.g. resolved, improved, sequel, unknown) Comments, if relevant (e.g. causality assessment, relationship) [type] [no.] [no.] [age] / [sex] [country, site] [as recorded] [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] [type] [no.] [no.] [age] / [sex] [country, site] [as recorded] [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] [type] [no.] [no.] [age] / [sex] [country, site] [as recorded] [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] [type] [no.] [no.] [age] / [sex] [country, site] [as recorded] [text] [dd/mm/yyyy] [dd/mm/yyyy] [text] [text] Signature and approval Place / date [place and date] Name and signature of sponsor-investigator Appendix SUSAR reports [no. or n/a] If applicable, please list the reports including reference number [free text]
ClinO_annual_safety_report.docx