Table 3.

Treatment-Related AEs Occurring at Any Grade in ≥5% of Patients or at Grade ≥3 and AEs of Special Interest

N = 35	Any Grade	Grade 3	Grade 4	Grade 5
TRAE	25 (71.4)	5 (14.3)	1 (2.9)	1 (2.9)
Gingival bleeding	6 (17.1)	0	0	0
Asthenia	5 (14.3)	0	0	0
Rash	4 (11.4)	0	0	0
Rash maculopapular	4 (11.4)	0	0	0
Pruritus	4 (11.4)	0	0	0
Rash papular	3 (8.6)	1 (2.9)	0	0
Arthralgia	3 (8.6)	0	0	0
Diarrhea	2 (5.7)	1 (2.9)	0	0
Keratoacanthoma	2 (5.7)	0	0	0
Eczema	2 (5.7)	1 (2.9)	0	0
Anemia	1 (2.9)	1 (2.9)	0	0
Alanine aminotransferase increased	1 (2.9)	1 (2.9)	0	0
Amylase increased	1 (2.9)	1 (2.9)	0	0
Lipase increased	1 (2.9)	1 (2.9)	1 (2.9)	0
Intracranial tumor hemorrhage	1 (2.9)	0	0	1 (2.9)
Papule	1 (2.9)	1 (2.9)	0	0
Any AESI
Skin lesions	4 (11.4)	0	0	0
Any immune-related adverse event	5 (14.3)	2 (5.7)	0	0
Immune-related rash	5 (14.3)	1 (2.9)	0	0
Immune-related endocrinopathies: thyroid disorders	2 (5.7)	0	0	0
Immune-related colitis	1 (2.9)	1 (2.9)	0	0

Data are n (%) in the safety set.

AESI, adverse event of special interest; TRAE, treatment-related adverse event.