Table 2.

Part A: treatment-emergent adverse events

System Organ Class Preferred Term	All Placebo (n = 10)	All BITS7201A (n = 31)	Cohort A 30-mg SC (n = 6)	Cohort B 90-mg SC (n = 6)	Cohort C 300-mg SC (n = 6)	Cohort D 300-mg IV (n = 7)	Cohort E 750-mg IV (n = 6)
Total number of TEAEs	8	15	4	1	3	3	4
Number of subjects with at least 1 TEAE	5 (50.0)	12 (38.7)	2 (33.3)	1 (16.7)	3 (50.0)	3 (42.9)	3 (50.0)
General disorders and administration site conditions	1 (10.0)	5 (16.1)	1 (16.7)	0	2 (33.3)	1 (14.3)	1 (16.7)
Fatigue	0	3 (9.7)	1 (16.7)	0	1 (16.7)	1 (14.3)	0
Chills	1 (10.0)	0	0	0	0	0	0
Infusion site erythema	0	1 (3.2)	0	0	0	0	1 (16.7)
Injection site reaction	0	1 (3.2)	0	0	1 (16.7)	0	0
Infections and infestations	1 (10.0)	4 (12.9)	1 (16.7)	0	0	2 (28.6)	1 (16.7)
Chlamydial infection	0	1 (3.2)	0	0	0	1 (14.3)	0
Furuncle	0	1 (3.2)	1 (16.7)	0	0	0	0
Otitis media	0	1 (3.2)	0	0	0	0	1 (16.7)
Pharyngitis streptococcal	0	1 (3.2)	0	0	0	1 (14.3)	0
Upper respiratory tract infection	0	1 (3.2)	0	0	0	0	1 (16.7)
Viral upper respiratory tract infection	1 (10.0)	0	0	0	0	0	0
Gastrointestinal disorders	2 (20.0)	1 (3.2)	0	0	1 (16.7)	0	0
Abdominal pain upper	0	1 (3.2)	0	0	1 (16.7)	0	0
Nausea	1 (10.0)	0	0	0	0	0	0
Vomiting	1 (10.0)	0	0	0	0	0	0
Ear and labyrinth disorders	1 (10.0)	1 (3.2)	1 (16.7)	0	0	0	0
Cerumen impaction	0	1 (3.2)	1 (16.7)	0	0	0	0
Ear pain	1 (10.0)	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders	1 (10.0)	1 (3.2)	0	0	0	0	1 (16.7)
Oropharyngeal pain	0	1 (3.2)	0	0	0	0	1 (16.7)
Rhinorrhoea	1 (10.0)	0	0	0	0	0	0
Injury, poisoning and procedural complications	0	1 (3.2)	1 (16.7)	0	0	0	0
Ligament sprain	0	1 (3.2)	1 (16.7)	0	0	0	0
Nervous system disorders	1 (10.0)	0	0	0	0	0	0
Dizziness	1 (10.0)	0	0	0	0	0	0
Psychiatric disorders	0	1 (3.2)	0	1 (16.7)	0	0	0
Libido decreased	0	1 (3.2)	0	1 (16.7)	0	0	0
Skin and subcutaneous tissue disorders	1 (10.0)	0	0	0	0	0	0
Dermatitis contact	1 (10.0)	0	0	0	0	0	0

Data are number of subjects (%). IV intravenous, SC subcutaneous, TEAE treatment emergent adverse event