TEAEs by preferred term reported in 10% or more patients
| TEAE, n (%) . | All grades (N = 231) . | Grade 3 (n = 209),∗ . | Grade 4 (n = 209),∗ . | Grade 5 (n = 209),∗ . |
|---|---|---|---|---|
| Any TEAE | 230 (99.6) | 156 (74.6) | 73 (34.9) | 11 (5.3) |
| Hematologic | ||||
| Anemia | 92 (39.8) | 34 (16.3) | 6 (2.9) | 0 |
| Thrombocytopenia | 76 (32.9) | 38 (18.2) | 27 (12.9) | 0 |
| Neutropenia | 56 (24.2) | 27 (12.9) | 14 (6.7) | 0 |
| Leukopenia | 35 (15.2) | 11 (5.3) | 10 (4.8) | 0 |
| White blood cell count decrease | 41 (17.8) | 16 (7.7) | 6 (2.9) | 0 |
| Neutrophil count decrease | 35 (15.2) | 13 (6.2) | 11 (5.3) | 0 |
| Nonhematologic | ||||
| Stomatitis | 152 (65.8) | 37 (17.7) | 4 (1.9) | 0 |
| Nausea | 78 (33.8) | 4 (1.9) | 0 | 0 |
| Pyrexia | 70 (30.3) | 4 (1.9) | 0 | 1 (0.5) |
| Vomiting | 56 (24.2) | 2 (1.0) | 0 | 0 |
| Constipation | 55 (23.8) | 0 | 0 | 0 |
| Fatigue | 52 (22.5) | 9 (4.3) | 2 (1.0) | 0 |
| Rash | 48 (20.8) | 4 (1.9) | 0 | 0 |
| Cough | 47 (20.4) | 2 (1.0) | 0 | 0 |
| Edema peripheral | 47 (20.4) | 0 | 0 | 0 |
| Diarrhea | 45 (19.5) | 3 (1.4) | 0 | 0 |
| Hypokalemia | 41 (17.8) | 13 (6.2) | 4 (1.9) | 0 |
| Alanine aminotransferase increase | 40 (17.3) | 7 (3.4) | 0 | 0 |
| Epistaxis | 39 (16.9) | 0 | 0 | 0 |
| Upper respiratory tract infection | 35 (15.2) | 5 (2.4) | 0 | 0 |
| Mucosal inflammation | 30 (13.0) | 6 (2.9) | 1 (0.5) | 0 |
| Aspartate aminotransferase increase | 27 (11.7) | 3 (1.4) | 0 | 0 |
| Pruritus | 25 (10.8) | 4 (1.9) | 0 | 0 |
| Decreased appetite | 24 (10.4) | 0 | 0 | 0 |
| TEAE, n (%) . | All grades (N = 231) . | Grade 3 (n = 209),∗ . | Grade 4 (n = 209),∗ . | Grade 5 (n = 209),∗ . |
|---|---|---|---|---|
| Any TEAE | 230 (99.6) | 156 (74.6) | 73 (34.9) | 11 (5.3) |
| Hematologic | ||||
| Anemia | 92 (39.8) | 34 (16.3) | 6 (2.9) | 0 |
| Thrombocytopenia | 76 (32.9) | 38 (18.2) | 27 (12.9) | 0 |
| Neutropenia | 56 (24.2) | 27 (12.9) | 14 (6.7) | 0 |
| Leukopenia | 35 (15.2) | 11 (5.3) | 10 (4.8) | 0 |
| White blood cell count decrease | 41 (17.8) | 16 (7.7) | 6 (2.9) | 0 |
| Neutrophil count decrease | 35 (15.2) | 13 (6.2) | 11 (5.3) | 0 |
| Nonhematologic | ||||
| Stomatitis | 152 (65.8) | 37 (17.7) | 4 (1.9) | 0 |
| Nausea | 78 (33.8) | 4 (1.9) | 0 | 0 |
| Pyrexia | 70 (30.3) | 4 (1.9) | 0 | 1 (0.5) |
| Vomiting | 56 (24.2) | 2 (1.0) | 0 | 0 |
| Constipation | 55 (23.8) | 0 | 0 | 0 |
| Fatigue | 52 (22.5) | 9 (4.3) | 2 (1.0) | 0 |
| Rash | 48 (20.8) | 4 (1.9) | 0 | 0 |
| Cough | 47 (20.4) | 2 (1.0) | 0 | 0 |
| Edema peripheral | 47 (20.4) | 0 | 0 | 0 |
| Diarrhea | 45 (19.5) | 3 (1.4) | 0 | 0 |
| Hypokalemia | 41 (17.8) | 13 (6.2) | 4 (1.9) | 0 |
| Alanine aminotransferase increase | 40 (17.3) | 7 (3.4) | 0 | 0 |
| Epistaxis | 39 (16.9) | 0 | 0 | 0 |
| Upper respiratory tract infection | 35 (15.2) | 5 (2.4) | 0 | 0 |
| Mucosal inflammation | 30 (13.0) | 6 (2.9) | 1 (0.5) | 0 |
| Aspartate aminotransferase increase | 27 (11.7) | 3 (1.4) | 0 | 0 |
| Pruritus | 25 (10.8) | 4 (1.9) | 0 | 0 |
| Decreased appetite | 24 (10.4) | 0 | 0 | 0 |
Patients could have >1 TEAE in any category.
Excludes study PDX-JP121 due to lack of accessible data.