English — reviewed original text

MEDICINES CONTROL AGENCY MCA THE GAMBIA SERIOUS ADVERSE EVENT (SAE) MCA-F-501/09 REPORT FORM MEDICINES CONTROL AGENCY Off Bertil Harding Highway, Kotu East, Kanifing Municipality, P.O. Box 3162, Serekunda, The Gambia Website: www.mca.gm; E-mail: info@mca.gm; Tel. No.: +2204380632 Protocol Number MCA CT No PACTR No Other numbers Principal Investi- gator Clinical Trial Site PARTICIPANT INFORMATION (at time of SAE onset) Participant Age Sex Date of Birth ID Day/Month/Year SERIOUS ADVERSE EVENT Outcome of Event Event onset Day/Month/Year ☐ Ongoing ☐ Recovered ☐ Unknown Tick all appropriate to adverse event ☐ Participant died ☐ Involved or prolonged hospitalisation ☐ Life threatening ☐ Involved in persistent orsignificant disability or incapacity Describe event(s) in detail (including relevant tests/lab data) MCA-F-501/09, version 2 – 24 January 2025 Page 1 of 2

Serious Adverse Event Report MCA The Gambia INVESTIGATIONAL MEDICINAL PRODUCT INFORMATION Blinded: ☐ Yes ☐ No Start date Stop date IMP Name/Identifier Route Daily Dose/Unit Day/Month/Year Day/Month/Year CONCOMITANT MEDICATION OR AUXILIARY MEDICINE (exclude those used to treat event) Start date Stop date Generic name Indication Daily Dose Route Day/Month/Year Day/Month/Year ASSESSMENT OF CAUSALITY WITH IMP SAE is related to IMP: ☐ Definite ☐ Probable ☐ Possible ☐ Unlikely ☐ Unrelated Did event reappear Did event abate after stopping IMP ☐ Yes ☐ No ☐ NA after IMP reintroduc- ☐ Yes ☐ No ☐ NA tion TYPE OF REPORT Date of this re- Date site aware of port Day/Month/Year SAE Day/Month/Year ☐ Initial Report ☐ Follow-up report # _____ Principal Investigator Signature Date OFFICIAL USE Date received: MCA SAE number: Comments: MCA-F-501/09, version 2 – 24 January 2025 Page 2 of 2