Table 3. Treatment-Emergent Adverse Events Occurring in 5% or More of Participants and SAEs (Safety Population).

Characteristic	Participants, No. (%)
	Placebo (n = 158)	Edonerpic Maleate, 224 mg (n = 166)	Edonerpic Maleate, 448 mg (n = 158)
Patient-days exposure, mean (SD)	341.6 (76.9)	303.4 (111.2)	304.2 (116.1)
Patients with at least 1 adverse event	122 (77.2)	134 (80.7)	136 (86.1)
Total adverse events, No.	446	470	472
Patients with at least 1 SAE	20 (12.7)	25 (15.1)	26 (16.5)
Total SAEs, No.	25	35	34
Deaths, No.	0	2 (1.2)	2 (1.3)
Patients with an SAE considered related	3 (1.9)	3 (1.8)	2 (1.3)
Total SAEs considered related, No.	4	3	3
Adverse events (≥5%, MEDRA terms)
Nasopharyngitis	9 (5.7)	4 (2.4)	4 (2.5)
Urinary tract infection	22 (13.9)	17 (10.2)	21 (13.3)
Agitation	14 (8.9)	5 (3.0)	4 (2.5)
Anxiety	12 (7.6)	9 (5.4)	7 (4.4)
Depression	7 (4.4)	6 (3.6)	8 (5.1)
Dizziness	3 (1.9)	7 (4.2)	11 (7.0)
Headache	10 (6.3)	16 (9.6)	9 (5.7)
Diarrhea	20 (12.7)	34 (20.5)	49 (31.0)
Nausea	6 (3.8)	13 (7.8)	9 (5.7)
Vomiting	7 (4.4)	8 (4.8)	9 (5.7)
Weight decreased	3 (1.9)	4 (2.4)	8 (5.1)
Falls	17 (10.8)	14 (8.4)	12 (7.6)
SAEs (>1 in any group)
Myocardial infarction or cardiac arrest	2 (1.3)	1 (0.6)	2 (1.3)
Chest pain	2 (1.3)	2 (1.3)	0
Urinary tract infection	1 (0.6)	1 (0.6)	2 (1.3)
Cellulitis	0	0	2 (1.3)
Sepsis	0	2 (1.3)	0
Fractures	2 (1.3)	3 (1.8)	3 (1.9)
Dehydration	0	2 (1.3)	2 (1.3)
Breast cancer	0	2 (1.3)	0
Cerebrovascular accident or hemorrhage	0	3 (1.8)	0
Transient ischemic attack	0	0	2 (1.3)
Syncope	3 (1.9)	2 (1.3)	0
Agitation	2 (1.3)	0	0
Confusional state and delirium	1 (0.6)	2 (1.3)	4 (2.6)

Abbreviations: MEDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.