^*Assessment by the investigator determined that the death was unrelated to the study drug.

^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 one 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 one dose of AJOVY®, 225 mg.

^bAdverse events shown include those reported in more than 2% of patients in any group.

^cAspartate aminotransferase or alanine aminotransferase at least three times the upper limit of normal.

^dTotal bilirubin at least two times the upper limit of normal.

^ePresence of three components: aspartate aminotransferase or alanine aminotransferase at least three times the upper limit of normal; total bilirubin at least two times the upper limit of normal; and other reason to explain these increases (eg, viral hepatitis A, B, or C; liver disease; or drug capable of causing injury).

^fOne 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.

 

 

^*Shown are data collected during the double-blind, placebo-controlled intervention period. The safety population included all the patients who underwent randomisation and received at least one dose of a trial regimen. ULN denotes upper limit of the normal range.

^†One serious adverse event led to discontinuation of the trial; an event of suicidal ideation (assessed by the investigator as being moderate in severity and unrelated to the trial regimen) was reported in a patient in AJOVY® monthly group who had a history of depression.

^‡One death occurred in the AJOVY® quarterly group as a result of chronic obstructive pulmonary disease; this was determined by the investigator and sponsor to be unrelated to the trial regimen.

^§Patients could have more than one type of possible trial-agent-induced liver injury.

^¶An event was reported in one additional patient but was inadvertently omitted as an adverse event of special interest.

ULN, upper limit of normal