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) |
| 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.