Table 3. Summary of TEAEs (Safety Population).

	No. (%)
	Eptinezumab (n = 238)	Placebo (n = 242)
Any TEAEa	26 (10.9)	25 (10.3)
Any TEAE of special interest	10 (4.2)	3 (1.2)
Any TEAE leading to infusion interruption	3 (1.3)	2 (0.8)
Infusion site extravasation	2 (0.8)	2 (0.8)
Hypersensitivityb	1 (0.4)	0
Serious TEAEs	0	0
TEAEs in >1 patient in either group
Hypersensitivityb	5 (2.1)	0
Influenza	2 (0.8)	2 (0.8)
Infusion site extravasation	2 (0.8)	2 (0.8)
Upper respiratory tract infection	2 (0.8)	2 (0.8)
Back pain	0	2 (0.8)
Nausea	0	2 (0.8)
TEAEs of special interest
Hypersensitivityb	5 (2.1)	0
Infusion site extravasation	2 (0.8)	2 (0.8)
Cough	1 (0.4)	0
Dyspnea	1 (0.4)	0
Allergic pruritus	1 (0.4)	0
Allergic rhinitis	1 (0.4)	0
Syncope	1 (0.4)	0
Increased transaminase levels	1 (0.4)	0
Oropharyngeal pain	0	1 (0.4)

Abbreviation: TEAE, treatment-emergent adverse event.

^aVerbatim descriptions of all adverse events were coded to the Medical Dictionary for Regulatory Activities, version 20.1, and classified by system organ class and preferred term. Investigators monitored the occurrence of adverse events for each patient from the time of informed consent through the course of the study. Adverse events may have been reported by a patient, a caregiver, or the investigative site through site personnel open-ended questioning, physical examination, laboratory tests, documentation in medical records, or other means.

^bTEAEs coded to the preferred term hypersensitivity were based on the sponsor’s established framework for evaluating individual symptoms or symptom constellations occurring on days of infusion.¹¹ The clinical presentation of each of these events was reported as allergic reaction.