Table 4.

TRAEs (any grade in ≥5% of patients or grade ≥3 in any patient) and IRRs

	N=156
	Any grade	Grade ≥3
Any TRAE, n (%)*	107 (68.6)	19 (12.2)
Fatigue	32 (20.5)	4 (2.6)
Nausea	19 (12.2)	0
Hypothyroidism	14 (9.0)	0
Diarrhea	12 (7.7)	0
Chills	11 (7.1)	0
Decreased appetite	10 (6.4)	1 (0.6)
Arthralgia	9 (5.8)	0
Dry skin	9 (5.8)	0
Pruritus	8 (5.1)	0
Fever	8 (5.1)	0
Vomiting	8 (5.1)	0
Pneumonitis	5 (3.2)	1 (0.6)
Lipase increased	4 (2.6)	1 (0.6)
Hypokalemia	2 (1.3)	1 (0.6)
Hyponatremia	2 (1.3)	1 (0.6)
Acute respiratory distress syndrome	1 (0.6)	1 (0.6)
Endocrine disorder	1 (0.6)	1 (0.6)
Hypertension	1 (0.6)	1 (0.6)
Hypoxia	1 (0.6)	1 (0.6)
Musculoskeletal chest pain	1 (0.6)	1 (0.6)
Nephrotic syndrome	1 (0.6)	1 (0.6)
Pneumothorax	1 (0.6)	1 (0.6)
IRR, n (%)†	40 (25.6)	5 (3.2)

*Incidence of treatment-related IRR based on the single MedDRA preferred term is not listed.

†Composite term, which includes AEs categorized as IRR, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of or day after infusion, in addition to signs and symptoms of IRR that occurred on the same day of infusion and resolved within 2 days (including AEs classified by investigators as related or unrelated to treatment).

AE, adverse event; IRR, infusion-related reaction; MedDRA, Medical Dictionary for Regulatory Activities; TRAE, treatment-related adverse event.