Table 3.

Treatment-related AEs of any grade that occurred in ≥5 patients or of ≥grade 3 that occurred in ≥2 patients.

	N = 107
	Any grade	Grade ≥3
Any,a n (%)	81 (75.7)	23 (21.5)
Led to death, n (%)	1 (0.9)	1 (0.9)
Specific events, n (%)
Fatigue	24 (22.4)	1 (0.9)
Diarrhea	14 (13.1)	1 (0.9)
Asthenia	12 (11.2)	1 (0.9)
Pruritus	12 (11.2)	1 (0.9)
Hypothyroidism	11 (10.3)	0
Rash	11 (10.3)	1 (0.9)
Decreased appetite	11 (10.3)	0
Nausea	8 (7.5)	0
Arthralgia	7 (6.5)	0
Headache	6 (5.6)	0
Vomiting	5 (4.7)	0
Maculopapular rash	5 (4.7)	1 (0.9)
Colitis	2 (1.9)	2 (1.9)
Ulcerative colitis	2 (1.9)	2 (1.9)
Hypotension	2 (1.9)	2 (1.9)
Autoimmune hepatitis	2 (1.9)	2 (1.9)
Immune-mediated AEs and infusion reactions that occurred in ≥1 patient
Any, n (%)b	24 (22.4)	9 (8.4)
Led to death, n (%)	1 (0.9)	1 (0.9)
Specific events, n (%)
Hypothyroidism	11 (10.3)	0
Hyperthyroidism	4 (3.7)	0
Pneumonitis	3 (2.8)	0
Hepatitis	3 (2.8)	3 (2.8)
Severe skin reactions	3 (2.8)	3 (2.8)
Colitis	2 (1.9)	2 (1.9)
Adrenal insufficiency	2 (1.9)	1 (0.9)
Infusion reaction	1 (0.9)	0

Note: Data are presented as n (%), where n is the number of patients who experienced ≥1 episode of a given event. Relatedness to treatment was determined by the investigator. Immune-mediated events were based on a list of terms specified by the sponsor and considered regardless of attribution to treatment or immune relatedness by the investigator; related terms were included.

Abbreviation: AE, adverse event.