Table VII.

Adverse events across all treatment areas, filtered by P ≤ .050 and occurring more frequently in onabotulinumtoxinA than in placebo across all groups (DBPC population, treatment cycle 1, days 1-90)

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	282 (42.4)	85 (36.0)	NS	NS	NS	NS	273 (37.7)	84 (26.7)	122 (39.0)	45 (28.8)	1136 (33.1)	395 (29.1)
Eyelid ptosis	16 (2.4)	0	NS	NS	NS	NS	15 (2.1)	1 (0.3)	NS	NS	34 (1.0)	1 (0.1)
Eyelid sensory disorder	21 (3.2)	1 (0.4)	NS	NS	NS	NS	NS	NS	NS	NS	25 (0.7)	1 (0.1)
Skin tightness	NS	NS	NS	NS	NS	NS	10 (1.4)	0	NS	NS	22 (0.6)	1 (0.1)
Brow ptosis	NS	NS	NS	NS	NS	NS	11 (1.5)	0	NS	NS	20 (0.6)	0
Eyelid edema	NS	NS	5 (0.4)	0	NS	NS	NS	NS	NS	NS	12 (0.3)	0
Facial pain	NS	NS	NS	NS	NS	NS	NS	NS	NS	NS	12 (0.3)	0
Injection site hemorrhage	NS	NS	8 (0.6)	1 (0.1)	NS	NS	NS	NS	NS	NS	NS	NS
Cough	NS	NS	6 (0.5)	0	NS	NS	NS	NS	NS	NS	NS	NS
Arthropod bite	NS	NS	4 (0.3)	0	NS	NS	NS	NS	NS	NS	NS	NS
Injection site paresthesia	NS	NS	4 (0.3)	0	NS	NS	NS	NS	NS	NS	NS	NS
Head discomfort	NS	NS	NS	NS	NS	NS	10 (1.4)	0	NS	NS	NS	NS
Nasopharyngitis	N/A	N/A	NS	NS	NS	NS	NS	NS	22 (7.0)	3 (1.9)	NS	NS

Included only statistically significant adverse events (P ≤ .050) and occurring more frequently in the onabotulinumtoxinA treatment group across all treatment areas in the DBPC population. Statistical testing was based on a fixed-effects meta-analysis model using both the Peto method and the Mantel–Haenszel method. The minimum P value between the 2 methods was used.

CFL, Crow’s feet lines; DBPC, double-blind placebo-controlled; FHL, forehead lines; GL, glabellar lines; N/A, not applicable; NS, not significant; OnabotA, onabotulinumtoxinA.