. 2024 Sep 16;42(36):4271–4281. doi: 10.1200/JCO-24-01798

TABLE 4.

Treatment-Emergent Adverse Events of Special Interest (safety analysis set)

Adverse Events Commonly Associated with Androgen Receptor Pathway Inhibitors	Darolutamide + ADT (n = 445^a)		Placebo + ADT (n = 221^a)
	No. of Patients (%)	EAIR^b/100 PY	No. of Patients (%)	EAIR^b/100 PY
Hypertension^c	42 (9.4)	5.5	21 (9.5)	6.7
Vasodilatation and flushing	41 (9.2)	5.6	16 (7.2)	5.0
Diabetes mellitus and hyperglycemia	40 (9.0)	5.3	21 (9.5)	6.7
Cardiac arrhythmias^c	39 (8.8)	5.1	15 (6.8)	4.7
Fatigue	25 (5.6)	3.2	18 (8.1)	5.7
Rash^d	19 (4.3)	2.4	8 (3.6)	2.4
Bone fracture^e	18 (4.0)	2.3	5 (2.3)	1.5
Coronary artery disorders^c	16 (3.6)	2.0	3 (1.4)	0.9
Decreased weight	14 (3.1)	1.8	6 (2.7)	1.8
Mental-impairment disorder^c	7 (1.6)	0.9	1 (0.5)	0.3
Falls, including accident	6 (1.3)	0.8	2 (0.9)	0.6
Heart failure^c	4 (0.9)	0.5	2 (0.9)	0.6
Depressed-mood disorder^c	2 (0.4)	0.2	2 (0.9)	0.6
Cerebral ischemia	1 (0.2)	0.1	3 (1.4)	0.9

Abbreviations: ADT, androgen-deprivation therapy; EAIR, exposure-adjusted incidence rate; MedDRA, Medical Dictionary for Regulatory Activities; PY, patient years.

^{^a}

Two patients who were randomly assigned to the placebo group but received darolutamide are analyzed in the darolutamide group for the safety analysis set.

^{^b}

EAIR of treatment-emergent adverse events is defined as the number of patients with a given event divided by the total darolutamide/placebo treatment duration of all patients in years. The rate is expressed in 100 PY.

^{^c}

This category is a MedDRA High-Level Group Term.

^{^d}

This category combines the following MedDRA terms: rash, maculopapular rash, papular rash, pustular rash, and dermatitis.

^{^e}

Excluding pathologic fractures. This category combines the following MedDRA terms: any fractures and dislocations, limb fractures and dislocations, pelvic fractures and dislocations, spinal fractures and dislocations, and thoracic cage fractures and dislocations.