MEDICINES CONTROL AGENCY MCA THE GAMBIA LINE LISTING OF ADVERSE EVENTS (AES) & SERIOUS ADVERSE EVENTS (SAES) MCA-F-501/14 Protocol number: Title of Trial: Date of initial MCA approval: Name of PI Name of Coordinating Investigator (if applicable): Site(s)name/number: IMP: Period of reporting: PARTICIPANT ID REPORT DATE(s) SITE AGE/DOB (GENDER) IMP START DATE OF IMP EVENT DECRIPTION/ DIAGNOSIS DATE OF ONSET SAE CATEGORY (if applicable) AE CATEGORY (if applicable) OUTCOME RELATION- SHIP TO IMP Example 12/08/10 Initial 05 40yrs (F) AB 19/05/09 Angina 10/08/10 Hospitalised Died Not related MCA-F-501/14, Version 1 – 24 January 2025 Page 1 of 1
