aAdverse events were collected at each visit via inquiry and clinical laboratory tests. The safety population included all patients who were randomised and received at least 1 dose of study drug. If a patient had multiple types of adverse events, he/she was counted once for each type. One patient randomised to receive placebo inadvertently received 1 dose of AJOVY®, 225mg. Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.
bOne death occurred in the AJOVY® quarterly group as a result of diphenhydramine overdose (suicide); assessment by the investigator determined that the death was unrelated to treatment.
cLocal injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.
dAspartate aminotransferase or alanine aminotransferase ≥3 x ULN.
eTotal bilirubin ≥2 x ULN.
fPresence of 3 components: aspartate aminotransferase or alanine aminotransferase ≥3 x ULN; total bilirubin ≥2 x ULN; and no other reason to explain these increases (eg, viral hepatitis A, B, or C; liver disease; or drug capable of causing injury).
gOne patient in the placebo group had a serious adverse event of drug hypersensitivity that was assessed as severe; the event was considered to be a generalised allergic reaction to ceftriaxone.
Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.