Table 3.

TRAEs of any grade in ≥2 patients or any grade 3 events in any patient (N=32)

	Any grade	Grade 3
Patients with any TRAE	22 (69)	11 (34)
Asthenia	5 (16)	0
Hypothyroidism	5 (16)	0
Pruritus	5 (16)	0
Rash maculopapular	5 (16)	2 (6)
ALT increased	4 (13)	1 (3)
AST increased	4 (13)	1 (3)
Stomatitis	3 (9)	0
Anemia	2 (6)	1 (3)
Decreased appetite	2 (6)	0
Diarrhea	2 (6)	0
Fatigue	2 (6)	0
Musculoskeletal pain	2 (6)	0
Hyperthyroidism	2 (6)	1 (3)
Colitis	1 (3)	1 (3)
Diabetic ketoacidosis	1 (3)	1 (3)
Hyperglycemia	1 (3)	1 (3)
Hyperkeratosis follicularis and parafollicularis	1 (3)	1 (3)
GGT increased	1 (3)	1 (3)
Lipase increased	1 (3)	1 (3)
Skin lesions*	4 (13)	2 (6)
Keratoacanthoma	3 (9)	1 (3)
SCC of skin	2 (6)	1 (3)

Data are number (%) unless otherwise stated.

*Includes MedDRA V.21.0 preferred terms ‘SCC of skin’, ‘basal cell carcinoma’, ‘keratoacanthoma’, ‘hyperkeratosis’ and ‘actinic keratosis’. In addition to those shown, 1 patient who reported keratoacanthoma and SCC of skin (as above) also reported grade 2 actinic keratosis and grade 2 basal cell carcinoma.

ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyltransferase; SCC, squamous cell carcinoma; TRAE, treatment-related adverse event.