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Vitamin B12 is a water-soluble vitamin crucial in forming healthy red blood cells, maintaining cell metabolism and the functioning of the brain and nerve cells, and synthesizing genetic materials like DNA

These compounds differ from larger peptide medications such as semaglutide, which is used in well-known drugs including Ozempic, Wegovy, and Rybelsus

Nausea tends to be mild and typically subsides within a few weeks

Definition Results in death Life-threatening Requires or prolongs hospitalization Results in persistent/significant disability/incapacity Congenital anomaly/birth defect OR action on the part of a physician is necessary to avert any of the above (ICH E2A) Some sponsors/protocols include Grade III and IV laboratory abnormalities as requiring expedited reporting Serious Adverse Events A SERIOUS Adverse Event is a regulatory, not clinical definition Reporting for SAEs is expedited