Table 5.

Summary of treatment emergent adverse events (TEAE)

	Number (%) of subjects
	IV DHE 1.0 mg (n = 24)	MAP0004 1.0 mg (n = 24)	Placebo (n = 24)
Reporting at least one
TEAE	19 (79.2)	10 (41.7)	6 (25.0)
Study drug related	19 (79.2)	6 (25.0)	4 (16.7)
TEAE
TEAE leading to discontinuation	1 (4.2)	0	0
Serious TEAE	0	0	0
TEAE by severity
Mild	12 (63.2)	9 (90.0)	6 (100.0)
Moderate	7 (36.8)	1 (10.0)	0
Severe	0	0	0
	IV DHE 1.0 mg (n = 20)	MAP0004 1.0 mg (n = 20)	Placebo (n = 20)
TEAE occurring at least twice
Headache	6 (30.0)	5 (25.0)	1 (5.0)
Nausea	10 (50.0)	1 (5.0)	0
Feeling hot	8 (40.0)	0	0
Pharmaceutical product complaint (taste)	4 (20.0)	2 (10.0)	1 (5.0)
Dizziness	3 (15.0)	2 (10.0)	1 (5.0)
Burning sensation	4 (20.0)	0	0
Paresthesia	3 (15.0)	0	0
Flushing	2 (10.0)	0	1 (5.0)
Chest discomfort	2 (10.0)	0	0
Head discomfort	2 (10.0)	0	0
Vomiting	2 (10.0)	0	0

Abbreviations: TEAE, treatment emergent adverse events; DHE, dihydroergotamine; IV, intravenous.