TABLE 6.

Adverse events leading to study discontinuations, reported by length of exposure in the six pooled studies

ADVERSE EVENT	DISCONTINUATIONS, N (%)
	≤4 Months†		≤12 Months‡
	BIM 0.03% (n=562)	VEH (n=379)	BIM 0.03% (n=680)	VEH (n=379)
Overall subject discontinuations*	17 (3.0)	7 (1.8)	22 (3.2)	9 (2.4)
Erythema of eyelid	1 (0.2)	1 (0.3)	3 (0.4)	1 (0.3)
Conjunctival hyperemia	3 (0.5)	0	3 (0.4)	0
Dry eye	3 (0.5)	0	3 (0.4)	0
Eye irritation	2 (0.4)	0	2 (0.3)	0
Contact dermatitis	2 (0.4)	0	2 (0.3)	0
Metastatic breast cancer	1 (0.2)	0	2 (0.3)	0
IOP decreased	1 (0.2)	1 (0.3)	1 (0.1)	1 (0.3)
Conjunctivitis allergic	1 (0.2)	0	1 (0.1)	0
Enophthalmos	1 (0.2)	0	1 (0.1)	0
Eye pruritus	1 (0.2)	0	1 (0.1)	0
Eye inflammation	1 (0.2)	0	1 (0.1)	0
Eyelid margin crusting	1 (0.2)	0	1 (0.1)	0
Increased lacrimation	0	0	1 (0.1)	0
Eyelid exfoliation	0	0	1 (0.1)	0
Eyelid edema	0	0	1 (0.1)	0
Eyelids pruritus	0	0	1 (0.1)	0
Conjunctival hemorrhage	0	1 (0.3)	0	1 (0.3)
Breast cancer	0	1 (0.3)	1 (0.1)	1 (0.3)
Cardiac arrest	1 (0.2)	0	1 (0.1)	0
Vertigo	1 (0.2)	0	1 (0.1)	0
Ovarian cancer§	1 (0.2)	0	1 (0.2)	0
Facial pain	1 (0.2)	0	1 (0.1)	0
Pulmonary embolism	1 (0.2)	0	1 (0.1)	0
Eczema	1 (0.2)	0	1 (0.1)	0
Dry mouth	0	1 (0.3)	0	1 (0.3)
Hordeolum	0	1 (0.3)	0	1 (0.3)
Dissociative disorder	0	1 (0.3)	0	1 (0.3)
Type 2 diabetes mellitus	0	0	0	1 (0.3)
Lymphoma	0	0	0	1 (0.3)

^*Some subjects reported more than one AE leading to discontinuation

^†Subjects in Study 5 are not included in the analysis up to four months.

^‡Up to six months for vehicle group.

^§Percentage was calculated based on the number of females in each group.

BIM=bimatoprost; IOP=intraocular pressure; VEH=vehicle