Supplementary Table 4.

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term: Treatment Phase and Short-Term Safety Phase, Safety Population

Variable	Placebo/placebo (n = 11)	Placebo/SER-287 weekly (n = 15)	Vancomycin/SER-287 weekly (n = 17)	Vancomycin/SER-287 daily (n = 15)	All subjects receiving any dose of SER-287 (n = 47)
Subjects with at least 1 TEAE	7 (63.6)	9 (60.0)	13 (76.5)	7 (46.7)	29 (61.7)
Gastrointestinal disorders	5 (45.5)	7 (46.7)	7 (41.2)	1 (6.7)	15 (31.9)
Abdominal distension	0	0	1 (5.9)	0	1 (2.1)
Abdominal pain	1 (9.1)	3 (20.0)	4 (23.5)	0	7 (14.9)
Abdominal pain upper	0	1 (6.7)	0	0	1 (2.1)
Abnormal feces	0	0	1 (5.9)	0	1 (2.1)
Bowel movement irregularity	0	0	2 (11.8)	0	2 (4.3)
Colitis ulcerative	1 (9.1)	1 (6.7)	1 (5.9)	0	2 (4.3)
Constipation	0	1 (6.7)	0	1 (6.7)	2 (4.3)
Diarrhea	2 (18.2)	1 (6.7)	1 (5.9)	0	2 (4.3)
Diarrhea hemorrhagic	1 (9.1)	0	0	0	0
Dyspepsia	1 (9.1)	0	0	0	0
Flatulence	0	0	2 (11.8)	0	2 (4.3)
Frequent bowel movements	0	1 (6.7)	0	0	1 (2.1)
Gastroesophageal reflux disease	0	1 (6.7)	0	0	1 (2.1)
Mucous stools	0	0	1 (5.9)	0	1 (2.1)
Nausea	0	3 (20.0)	1 (5.9)	1 (6.7)	5 (10.6)
Esophagitis	0	0	1 (5.9)	0	1 (2.1)
Rectal discharge	0	1 (6.7)	0	0	1 (2.1)
Vomiting	0	1 (6.7)	1 (5.9)	0	2 (4.3)
General disorders and administration site conditions	1 (9.1)	0	3 (17.6)	1 (6.7)	4 (8.5)
Asthenia	0	0	1 (5.9)	0	1 (2.1)
Chest pain	0	0	1 (5.9)	0	1 (2.1)
Influenza-like illness	0	0	1 (5.9)	0	1 (2.1)
Edema peripheral	0	0	0	1 (6.7)	1 (2.1)
Pyrexia	1 (9.1)	0	0	0	0
Immune system disorders	0	0	1 (5.9)	0	1 (2.1)
Hypersensitivity	0	0	1 (5.9)	0	1 (2.1)
Infections and infestations	3 (27.3)	1 (6.7)	5 (29.4)	4 (26.7)	10 (21.3)
Cellulitis	0	0	1 (5.9)	0	1 (2.1)
Nasopharyngitis	0	0	1 (5.9)	1 (6.7)	2 (4.3)
Oral candidiasis	1 (9.1)	0	0	0	0
Otitis externa	1 (9.1)	0	0	0	0
Pneumonia	0	0	0	1 (6.7)	1 (2.1)
Pyelonephritis	0	1 (6.7)	0	0	1 (2.1)
Rhinitis	0	1 (6.7)	0	1 (6.7)	2 (4.3)
Sinusitis	0	0	1 (5.9)	0	1 (2.1)
Tooth infection	1 (9.1)	0	0	0	0
Upper respiratory tract infection	0	0	1 (5.9)	2 (13.3)	3 (6.4)
Urinary tract infection	0	1 (6.7)	0	0	1 (2.1)
Viral upper respiratory tract infection	0	0	1 (5.9)	0	1 (2.1)
Injury, poisoning and procedural complications	2 (18.2)	0	0	0	0
Contusion	1 (9.1)	0	0	0	0
Limb injury	1 (9.1)	0	0	0	0
Muscle injury	1 (9.1)	0	0	0	0
Investigations	0	0	1 (5.9)	0	1 (2.1)
Nitrite urine present	0	0	1 (5.9)	0	1 (2.1)
White blood cells urine positive	0	0	1 (5.9)	0	1 (2.1)
Metabolism and nutrition disorders	0	0	1 (5.9)	1 (6.7)	2 (4.3)
Decreased appetite	0	0	1 (5.9)	0	1 (2.1)
Hypokalemia	0	0	0	1 (6.7)	1 (2.1)
Musculoskeletal and connective tissue disorders	0	2 (13.3)	1 (5.9)	2 (13.3)	5 (10.6)
Back pain	0	2 (13.3)	1 (5.9)	1 (6.7)	4 (8.5)
Muscle spasms	0	0	0	1 (6.7)	1 (2.1)
Nervous system disorders	0	0	1 (5.9)	3 (20.0)	4 (8.5)
Headache	0	0	1 (5.9)	3 (20.0)	4 (8.5)
Psychiatric disorders	0	0	0	1 (6.7)	1 (2.1)
Depression	0	0	0	1 (6.7)	1 (2.1)
Reproductive system and breast disorders	0	0	1 (5.9)	0	1 (2.1)
Pelvic pain	0	0	1 (5.9)	0	1 (2.1)
Respiratory, thoracic and mediastinal disorders	0	1 (6.7)	2 (11.8)	1 (6.7)	4 (8.5)
Cough	0	1 (6.7)	0	1 (6.7)	2 (4.3)
Nasal congestion	0	0	1 (5.9)	0	1 (2.1)
Rhinitis allergic	0	0	1 (5.9)	0	1 (2.1)
Skin and subcutaneous tissue disorders	0	0	1 (5.9)	2 (13.3)	3 (6.4)
Hidradenitis	0	0	0	1 (6.7)	1 (2.1)
Skin reaction	0	0	1 (5.9)	0	1 (2.1)
Swelling face	0	0	0	1 (6.7)	1 (2.1)

NOTE. Values are n (%).

TEAE, treatment-emergent adverse event.