TABLE 7.

Treatment-related adverse events that occurred in the intramuscular administration study.

	Pilot study		Pivotal study 2
	T (400 mg PE) (N = 6)	T (600 mg PE) (N = 6)	T (400 mg PE) (N = 34)	R1 (400 mg PE) (N = 31)
All AEs	4 (66.7)	5 (83.3)	12 (35.3)	14 (45.2)
AE grade
Grade I	3 (50.0)	5 (83.3)	11 (32.4)	13 (41.9)
Grade II	1 (16.7)	3 (50.0)	0 (0.0)	1 (3.2)
Grade III	0 (0.0)	0 (0.0)	1 (2.9)	0 (0.0)
Drug-related AEs	4 (66.7)	5 (83.3)	11 (32.4)	14 (45.2)
Dizziness	2 (33.3)	5 (83.3)	6 (17.6)	5 (16.1)
Pruritus	0 (0.0)	4 (66.7)	3 (8.8)	3 (9.7)
Vertigo	0 (0.0)	0 (0.0)	1 (2.9)	2 (6.5)
Dizziness	0 (0.0)	0 (0.0)	1 (2.9)	2 (6.5)
Hypertriglyceridemia	0 (0.0)	0 (0.0)	1 (2.9)	1 (3.2)
Headache	0 (0.0)	3 (50.0)	1 (2.9)	1 (3.2)
Urinary tract infection	0 (0.0)	0 (0.0)	1 (2.9)	0 (0.0)
Increased white blood cell count	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Elevated ALT	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Elevated AST	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Elevated serum creatinine	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Increased neutrophil count	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Hypesthesia	0 (0.0)	0 (0.0)	1 (2.9)	0 (0.0)
Ataxia	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Hidrosis	0 (0.0)	3 (50.0)	0 (0.0)	1 (3.2)
Hematuria	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Nausea	0 (0.0)	2 (33.3)	0 (0.0)	1 (3.2)
Abdominal discomfort	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Abdominal pain	0 (0.0)	0 (0.0)	1 (2.9)	0 (0.0)
Sinus bradycardia	0 (0.0)	1 (16.7)	0 (0.0)	1 (3.2)
Dry eye	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)
Oropharyngeal pain	0 (0.0)	1 (16.7)	0 (0.0)	0 (0.0)
Rash	0 (0.0)	1 (16.7)	0 (0.0)	0 (0.0)
Lacking in strength	0 (0.0)	3 (50.0)	0 (0.0)	0 (0.0)
Injection site pain	1 (16.7)	1 (16.7)	0 (0.0)	0 (0.0)
Diarrhea	1 (16.7)	0 (0.0)	0 (0.0)	0 (0.0)
Upper abdominal pain	0 (0.0)	1 (16.7)	0 (0.0)	0 (0.0)
Palpitations	0 (0.0)	1 (16.7)	0 (0.0)	0 (0.0)
Ophthalmodynia	0 (0.0)	4 (66.7)	0 (0.0)	0 (0.0)

AE, adverse event; data are presented as n (%): the number of subjects who developed any AEs (the incidence of the AEs).