Table 3.

TEAEs with CTCAE of grade 3 or higher occurring in 10% or more of patients, by SOC, preferred term, and maximum severity

SOC preferred term, N (%)	Part A (N = 55)	Part B (N = 26)	Part C (N = 14)	Part D (N = 22)	Part E (N = 3)	Overall (N = 120)
Number of patients with at least 1 TEAE of CTCAE, grade ≥3	46 (83.6)	24 (92.3)	12 (85.7)	21 (95.5)	2 (66.7)	105 (87.5)
Grade 3	12 (21.8)	10 (38.5)	5 (35.7)	11 (50.0)	1 (33.3)	39 (32.5)
Grade 4	32 (58.2)	12 (46.2)	4 (28.6)	9 (40.9)	1 (33.3)	58 (48.3)
Grade 5	2 (3.6)	2 (7.7)	3 (21.4)	1 (4.5)	0	8 (6.7)
Blood and lymphatic system disorders	27 (49.1)	12 (46.2)	9 (64.3)	12 (54.5)	1 (33.3)	61 (50.8)
Anemia	17 (30.9)	3 (11.5)	5 (35.7)	5 (22.7)	1 (33.3)	31 (25.8)
Febrile neutropenia	14 (25.5)	7 (26.9)	6 (42.9)	3 (13.6)	0	30 (25.0)
Leukopenia	5 (9.1)	0	4 (28.6)	3 (13.6)	0	12 (10.0)
Lymphopenia	6 (10.9)	2 (7.7)	4 (28.6)	6 (27.3)	0	18 (15.0)
Infections and infestations	25 (45.5)	9 (34.6)	5 (35.7)	7 (31.8)	1 (33.3)	47 (39.2)
Pneumonia	13 (23.6)	3 (11.5)	3 (21.4)	1 (4.5)	1 (33.3)	21 (17.5)
Investigations	27 (49.1)	9 (34.6)	5 (35.7)	9 (40.9)	1 (33.3)	51 (42.5)
Lymphocyte count decreased	10 (18.2)	2 (7.7)	0	1 (4.5)	0	13 (10.8)
Neutrophil count decreased	9 (16.4)	4 (15.4)	1 (7.1)	0	1 (33.3)	15 (12.5)
Platelet count decreased	8 (14.5)	2 (7.7)	1 (7.1)	2 (9.1)	1 (33.3)	14 (11.7)
White blood cell count decreased	12 (21.8)	2 (7.7)	0	2 (9.1)	0	16 (13.3)
Vascular disorders	8 (14.5)	2 (7.7)	3 (21.4)	6 (27.3)	0	19 (15.8)
Hypertension	6 (10.9)	1 (3.8)	2 (14.3)	4 (18.2)	0	13 (10.8)

Data are presented as number (percentage) of patients. The denominators for percentages are the number of patients treated in each group.

CTCAE, Common Terminology Criteria for Adverse Events.