TEAEs for all patients within and beyond 2 y of treatment
| AE preferred term . | Within the first 2 y of treatment; all patients, N = 49* . | After 2 y of treatment; all patients n = 21† . |
|---|---|---|
| Any AE (≥20% of total patients), n (%) | 49 (100) | 20 (95) |
| Upper respiratory tract infection | 31 (63) | 10 (48) |
| Diarrhea | 29 (59) | 7 (33) |
| Neutropenia | 27 (55) | 6 (29) |
| Nausea | 25 (51) | 5 (24) |
| Cough | 22 (45) | 2 (10) |
| Pyrexia | 20 (41) | 4 (19) |
| Fatigue | 18 (37) | 2 (10) |
| Headache | 16 (33) | 1 (5) |
| Anemia | 14 (29) | 2 (10) |
| Thrombocytopenia | 12 (24) | 2 (10) |
| Urinary tract infection | 11 (22) | 3 (14) |
| Vomiting | 11 (22) | 3 (14) |
| Nasal congestion | 10 (20) | 3 (14) |
| Pneumonia | 10 (20) | 3 (14) |
| Grade 3/4 (≥5% of total patients), n (%) | 40 (82) | 11 (52) |
| Neutropenia | 26 (53) | 4 (19)‡ |
| Thrombocytopenia | 8 (16) | 1 (5) |
| Anemia | 7 (14) | 0 |
| Leukopenia | 7 (14) | 3 (14) |
| Febrile neutropenia | 5 (10) | 0 |
| Decreased neutrophil count | 4 (8) | 0 |
| Lower respiratory tract infection | 3 (6) | 1 (5) |
| Lymphopenia | 3 (6) | 0 |
| Pneumonia | 3 (6) | 1 (5) |
| Pyrexia | 3 (6) | 1 (5) |
| SAEs (>2% of total patients), n (%) | 28 (57) | 9 (43) |
| Pyrexia | 5 (10) | 1 (5) |
| Febrile neutropenia | 4 (8) | 0 |
| Pneumonia | 4 (8) | 2 (10) |
| Lower respiratory tract infection | 3 (6) | 1 (5) |
| Diarrhea | 2 (4) | 1 (5) |
| Infusion-related reaction | 2 (4) | 0 |
| Osteoarthritis | 2 (4) | 2 (10) |
| Tumor lysis syndrome | 2 (4) | 0 |
| AE preferred term . | Within the first 2 y of treatment; all patients, N = 49* . | After 2 y of treatment; all patients n = 21† . |
|---|---|---|
| Any AE (≥20% of total patients), n (%) | 49 (100) | 20 (95) |
| Upper respiratory tract infection | 31 (63) | 10 (48) |
| Diarrhea | 29 (59) | 7 (33) |
| Neutropenia | 27 (55) | 6 (29) |
| Nausea | 25 (51) | 5 (24) |
| Cough | 22 (45) | 2 (10) |
| Pyrexia | 20 (41) | 4 (19) |
| Fatigue | 18 (37) | 2 (10) |
| Headache | 16 (33) | 1 (5) |
| Anemia | 14 (29) | 2 (10) |
| Thrombocytopenia | 12 (24) | 2 (10) |
| Urinary tract infection | 11 (22) | 3 (14) |
| Vomiting | 11 (22) | 3 (14) |
| Nasal congestion | 10 (20) | 3 (14) |
| Pneumonia | 10 (20) | 3 (14) |
| Grade 3/4 (≥5% of total patients), n (%) | 40 (82) | 11 (52) |
| Neutropenia | 26 (53) | 4 (19)‡ |
| Thrombocytopenia | 8 (16) | 1 (5) |
| Anemia | 7 (14) | 0 |
| Leukopenia | 7 (14) | 3 (14) |
| Febrile neutropenia | 5 (10) | 0 |
| Decreased neutrophil count | 4 (8) | 0 |
| Lower respiratory tract infection | 3 (6) | 1 (5) |
| Lymphopenia | 3 (6) | 0 |
| Pneumonia | 3 (6) | 1 (5) |
| Pyrexia | 3 (6) | 1 (5) |
| SAEs (>2% of total patients), n (%) | 28 (57) | 9 (43) |
| Pyrexia | 5 (10) | 1 (5) |
| Febrile neutropenia | 4 (8) | 0 |
| Pneumonia | 4 (8) | 2 (10) |
| Lower respiratory tract infection | 3 (6) | 1 (5) |
| Diarrhea | 2 (4) | 1 (5) |
| Infusion-related reaction | 2 (4) | 0 |
| Osteoarthritis | 2 (4) | 2 (10) |
| Tumor lysis syndrome | 2 (4) | 0 |