Table 2.
Incidence of TEAEs
| Preferred term, n (%) | Group 1 (n = 3) | Group 2 (n = 3) | Group 3 + expansion group (n = 32) | Overall (N = 38) | ||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
| Patients with any TEAEs | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 32 (100) | 32 (100) | 38 (100) | 38 (100) |
| Lymphocyte count decreased | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 31 (96.9) | 31 (96.9) | 37 (97.4) | 37 (97.4) |
| White blood cell count decreased | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 28 (87.5) | 28 (87.5) | 34 (89.5) | 34 (89.5) |
| Neutrophil count decreased | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 27 (84.4) | 27 (84.4) | 33 (86.8) | 33 (86.8) |
| Anemia | 2 (66.7) | 2 (66.7) | 2 (66.7) | 2 (66.7) | 23 (71.9) | 20 (62.5) | 27 (71.1) | 24 (63.2) |
| Fatigue | 3 (100) | 0 | 2 (66.7) | 0 | 19 (59.4) | 1 (3.1) | 24 (63.2) | 1 (2.6) |
| Nausea | 3 (100) | 0 | 2 (66.7) | 0 | 19 (59.4) | 0 | 24 (63.2) | 0 |
| Pyrexia | 1 (33.3) | 0 | 3 (100) | 0 | 18 (56.3) | 0 | 22 (57.9) | 0 |
| CRS | 1 (33.3) | 0 | 0 | 0 | 20 (62.5) | 2 (6.3) | 21 (55.3) | 2 (5.3) |
| Platelet count decreased | 2 (66.7) | 1 (33.3) | 1 (33.3) | 1 (33.3) | 18 (56.3) | 14 (43.8) | 21 (55.3) | 16 (42.1) |
| Vomiting | 2 (66.7) | 0 | 2 (66.7) | 0 | 15 (46.9) | 1 (3.1) | 19 (50.0) | 1 (2.6) |
| Decreased appetite | 3 (100) | 0 | 2 (66.7) | 0 | 11 (34.4) | 2 (6.3) | 16 (42.1) | 2 (5.3) |
| Dyspnea | 2 (66.7) | 0 | 2 (66.7) | 0 | 12 (37.5) | 1 (3.1) | 16 (42.1) | 1 (2.6) |
| Hypophosphatemia | 0 | 0 | 2 (66.7) | 2 (66.7) | 13 (40.6) | 11 (34.4) | 15 (39.5) | 13 (34.2) |
| Diarrhea | 2 (66.7) | 0 | 0 | 0 | 12 (37.5) | 0 | 14 (36.8) | 0 |
| Hypotension | 0 | 0 | 1 (33.3) | 1 (33.3) | 13 (40.6) | 3 (9.4) | 14 (3.8) | 4 (10.5) |
| Febrile neutropenia | 1 (33.3) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 9 (28.1) | 9 (28.1) | 12 (31.6) | 12 (31.6) |
| Hyponatremia | 2 (66.7) | 2 (66.7) | 1 (33.3) | 0 | 9 (28.1) | 6 (18.8) | 12 (31.6) | 8 (21.1) |
| Abdominal pain | 2 (66.7) | 0 | 2 (66.7) | 0 | 7 (21.9) | 1 (3.1) | 11 (28.9) | 1 (2.6) |
| Headache | 0 | 0 | 3 (100) | 0 | 7 (21.9) | 0 | 10 (26.3) | 0 |
| Arthralgia | 0 | 0 | 1 (33.3) | 0 | 8 (25.0) | 1 (3.1) | 9 (23.7) | 1 (2.6) |
| Aspartate aminotransferase increased | 0 | 0 | 1 (33.3) | 0 | 8 (25.0) | 1 (3.1) | 9 (23.7) | 1 (2.6) |
| Chills | 0 | 0 | 1 (33.3) | 0 | 8 (25.0) | 0 | 9 (23.7) | 0 |
| Dizziness | 1 (33.3) | 0 | 2 (66.7) | 0 | 6 (18.8) | 0 | 9 (23.7) | 0 |
| Alanine aminotransferase increased | 0 | 0 | 1 (33.3) | 0 | 7 (21.9) | 1 (3.1) | 8 (21.1) | 1 (2.6) |
| Alopecia | 1 (33.3) | 0 | 2 (66.7) | 0 | 5 (15.6) | 0 | 8 (21.1) | 0 |
| Pruritus | 0 | 0 | 1 (33.3) | 0 | 7 (21.9) | 0 | 8 (21.1) | 0 |
| Tumor pain | 0 | 0 | 0 | 0 | 8 (25.0) | 1 (3.1) | 8 (21.1) | 1 (2.6) |