TABLE A3.

Treatment-Emergent Grade 5 Adverse Events by MedDRA Preferred Term (safety analysis set)

Grade 5 Adverse Event, No. (%) of Patientsa	Darolutamide (n = 445)	Placebo (n = 221)
Any	21 (4.7)	12 (5.4)
Death (not otherwise specified)	2 (0.4)	2 (0.9)
Craniocerebral injury	2 (0.4)	0
Myocardial infarction	2 (0.4)	0
Septic shock	2 (0.4)	0
Sepsis	1 (0.2)	1 (0.5)
Acinetobacter sepsis	1 (0.2)	0
COVID-19 pneumonia	1 (0.2)	0
COVID-19 test positive	1 (0.2)	0
Disease progression	1 (0.2)	0
Dyspnea	1 (0.2)	0
Hyponatremia	1 (0.2)	0
Multiple organ dysfunction syndrome	1 (0.2)	0
Oncologic complication	1 (0.2)	0
Pneumonia, viral	1 (0.2)	0
Prostate cancer, metastatic	1 (0.2)	0
Pulmonary edema	1 (0.2)	0
Pulmonary sepsis	1 (0.2)	0
Sudden death	1 (0.2)	0
Urinary tract infection	1 (0.2)	0
Urosepsis	1 (0.2)	0
Acute coronary syndrome	0	1 (0.5)
Acute myocardial infarction	0	1 (0.5)
Cardiac arrest	0	1 (0.5)
Cerebral infarction	0	1 (0.5)
Gastrointestinal hemorrhage	0	1 (0.5)
Intestinal ischemia	0	1 (0.5)
Ischemic stroke	0	1 (0.5)
Pulmonary congestion	0	1 (0.5)
Pulmonary embolism	0	1 (0.5)
Renal failure	0	1 (0.5)
Respiratory failure	0	1 (0.5)

NOTE. MedDRA denotes Medical Dictionary for Regulatory Activities.

^a Patients may have had more than one grade 5 co-occurring adverse events.