Table V.

Adverse events across all treatment areas, filtered by P ≤ .050 (DBPC population, treatment cycle 1, days 1-90)

Preferred term, n (%)	OnabotA (N = 3431)	Placebo (N = 1359)	P value	Treatment group favored
Overall	1136 (33.1)	395 (29.1)	.0103	OnabotA
Eyelid ptosis	34 (1.0)	1 (0.1)	.0024	OnabotA
Eyelid sensory disorder	25 (0.7)	1 (0.1)	.0024	OnabotA
Skin tightness	22 (0.6)	1 (0.1)	.0179	OnabotA
Brow ptosis	20 (0.6)	0	.0098	OnabotA
Diarrhea	7 (0.2)	9 (0.7)	.0054	Placebo
Eyelid edema	12 (0.3)	0	.0214	OnabotA
Facial pain	12 (0.3)	0	.0285	OnabotA
Lower RTI	4 (0.1)	6 (0.4)	.0129	Placebo
Pneumonia	3 (0.1)	5 (0.4)	.0345	Placebo
Rash	2 (0.1)	4 (0.3)	.0276	Placebo
Gastroesophageal reflux disease	1 (0.0)	3 (0.2)	.0357	Placebo
Periodontitis	0	3 (0.2)	.0054	Placebo
Visual impairment	0	2 (0.1)	.0229	Placebo
Adjustment disorder∗	0	1 (0.1)	.0438	Placebo
Back injury	0	1 (0.1)	.0443	Placebo
Diabetes mellitus	0	1 (0.1)	.0443	Placebo
Fibromyalgia	0	1 (0.1)	.0443	Placebo
Gastrointestinal infection	0	1 (0.1)	.0438	Placebo
Leiomyoma	0	1 (0.1)	.0443	Placebo
Osteoarthritis	0	1 (0.1)	.0443	Placebo
Petechiae	0	1 (0.1)	.0443	Placebo
Perioral dermatitis	0	1 (0.1)	.0443	Placebo
Varicose vein	0	1 (0.1)	.0443	Placebo
Skin indentation	0	1 (0.1)	.0443	Placebo

Included only statistically significant adverse events (P ≤ .050) 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 is displayed.

DBPC, Double-blind placebo-controlled; OnabotA, onabotulinumtoxinA; RTI, respiratory tract infection.

^∗With depressed mood.