Table IX.

Serious adverse events occurring in ≥2 participants across all treatment areas (DBPC population, by treatment area)

Preferred term, n (%)	GL		CFL		CFL/GL		FHL/GL		FHL/GL/CFL		All
	OnabotA N = 665	Placebo N = 236	OnabotA N = 1324	Placebo N = 808	OnabotA N = 405	Placebo N = 306	OnabotA N = 724	Placebo N = 315	OnabotA N = 313	Placebo N = 156	OnabotA N = 3431	Placebo N = 1359
Overall	10 (1.5)	2 (0.8)	18 (1.4)	12 (1.5)	11 (2.7)	7 (2.3)	10 (1.4)	3 (1.0)	5 (1.6)	2 (1.3)	54 (1.6)	17 (1.3)
Basal cell carcinoma	0 (0.0)	0 (0.0)	4 (0.3)	0 (0.0)	2 (0.5)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	6 (0.2)	0 (0.0)
Breast cancer	2 (0.3)	0 (0.0)	0 (0.0)	1 (0.1)	0 (0.0)	1 (0.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.1)	1 (0.1)
Myocardial infarction	0 (0.0)	0 (0.0)	2 (0.2)	1 (0.1)	0 (0.0)	1 (0.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.1)	1 (0.1)
Pneumonia	0 (0.0)	0 (0.0)	1 (0.1)	1 (0.1)	1 (0.2)	1 (0.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.1)	1 (0.1)
Intervertebral disc protrusion	1 (0.2)	0 (0.0)	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.1)	0 (0.0)
Invasive ductal breast carcinoma	0 (0.0)	0 (0.0)	2 (0.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.1)	0 (0.0)
Overdose∗	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.3)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.1)	0 (0.0)

Included only serious adverse events occurring in ≥2 participants in either treatment group across all treatment areas in the DBPC population.

CFL, Crow’s feet lines; DBPC, double-blind placebo-controlled; FHL, forehead lines; GL, glabellar lines; onabotA, onabotulinumtoxinA.

^∗Overdose of alcohol, gabapentin, and zopiclone (n = 1) and of alcohol and co-codamol 30/500 (n = 1).