Table 3.

Profile of Treatment-Emergent Adverse Events

	Placebo N = 43	Edasalonexent N = 88 100 mg/kg/day	Overall N = 131
Treatment-Emergent Adverse Events	# Patients (%)
Any	41 (95.3)	85 (96.6)	126 (96.2)
Mild	31 (72.1)	53 (60.2)	84 (64.1)
Moderate	9 (20.9)	31 (35.2)	40 (30.5)
Severe (both unrelated)	1 (2.3)	1 (1.1)	2 (1.5)
Serious (both unrelated)	1 (2.3)	1 (1.1)	2 (1.5)
Withdrawal due to Adverse Event	0	1 (1.1)	1 (0.8)
Treatment-emergent events occurring in > 5%of patients
Diarrhea	12 (27.9)	54 (61.4)	66 (50.4)
Vomiting	11 (25.6)	29 (33.0)	40 (30.5)
Rash	2 (4.7)	20 (22.7)	22 (16.8)
Nasopharyngitis	9 (20.9)	19 (21.6)	28 (21.4)
Upper respiratory tract infection	5 (11.6)	18 (20.5)	23 (17.6)
Pyrexia	9 (20.9)	17 (19.3)	26 (19.8)
Abdominal pain upper	9 (20.9)	15 (17.0)	24 (18.3)
Fall	4 (9.3)	14 (15.9)	18 (13.7)
Cough	11 (25.6)	13 (14.8)	24 (18.3)
Headache	8 (18.6)	12 (13.6)	20 (15.3)
Influenza	2 (4.7)	10 (11.4)	12 (9.2)
Muscle spasms	1 (2.3)	10 (11.4)	11 (8.4)
Ear infection	5 (11.6)	7 (8.0)	12 (9.2)
Nausea	5 (11.6)	7 (8.0)	12 (9.2)
Pain in extremity	5 (11.6)	6 (6.8)	11 (8.4)
Constipation	3 (7.0)	6 (6.8)	9 (6.9)
Pharyngitis streptococcal	4 (9.3)	4 (4.5)	8 (6.1)
Rhinorrhea	5 (11.6)	3 (3.4)	8 (6.1)
Decreased appetite	2 (4.7)	6 (6.8)	8 (6.1)
Abdominal pain	1 (2.3)	7 (8.0)	8 (6.1)
Contusion	2 (4.7)	6 (6.8)	8 (6.1)
Epistaxis	1 (2.3)	6 (6.8)	7 (5.3)
Fatigue	0 (0.0)	6 (6.8)	6 (4.6)
Treatment-related events occurring in ≥2.0%of patients
Any	14 (32.6)	61 (69.3)	75 (57.3)
Diarrhea	8 (18.6)	45 (51.1)	53 (40.5)
Vomiting	2 (4.7)	14 (15.9)	16 (12.2)
Upper abdominal pain	4 (9.3)	7 (8.0)	11 (8.4)
Rash	0	9 (10.2)	9 (6.9)
Nausea	1 (2.3)	4 (4.5)	5 (3.8)
Abdominal pain	0	5 (5.7)	5 (3.8)
Abdominal discomfort	1 (2.3)	3 (3.4)	4 (3.1)
Headache	0	4 (4.5)	4 (3.1)
Fall	0	3 (3.4)	3 (2.3)
Decreased appetite	0	3 (3.4)	3 (2.3)