Most common (≥ 5%) study-related adverse events, including all grade 3 and 4 events
| . | Grade . | n (%) . | |||
|---|---|---|---|---|---|
| 1 . | 2 . | 3 . | 4 . | ||
| No. of patients with a study-related event | 2 (6) | 9 (29) | 8 (26) | 12 (39) | 31 (100) |
| Preferred term | |||||
| Nausea | 21 (68) | 6 (19) | 0 | 0 | 27 (87) |
| Pyrexia | 17 (55) | 2 (6) | 1 (3) | 0 | 20 (65) |
| Neutropenia | 0 | 3 (10) | 4 (13) | 12 (39) | 19 (61) |
| Chills | 10 (32) | 5 (16) | 1 (3) | 0 | 16 (52) |
| Vomiting | 10 (32) | 5 (16) | 0 | 0 | 15 (48) |
| Fatigue | 10 (32) | 2 (6) | 1 (3) | 0 | 13 (42) |
| Anemia | 3 (10) | 5 (16) | 2 (6) | 0 | 10 (32) |
| Constipation | 9 (29) | 0 | 1 (3) | 0 | 10 (32) |
| Diarrhea | 9 (29) | 1 (3) | 0 | 0 | 10 (32) |
| Hypotension | 5 (16) | 3 (10) | 0 | 0 | 8 (26) |
| Dyspnea | 4 (13) | 2 (6) | 1 (3) | 0 | 7 (23) |
| Headache | 7 (23) | 0 | 0 | 0 | 7 (23) |
| Leukopenia | 1 (3) | 0 | 4 (13) | 2 (6) | 7 (23) |
| Thrombocytopenia | 0 | 3 (10) | 3 (10) | 1 (3) | 7 (23) |
| Dizziness | 6 (19) | 0 | 0 | 0 | 6 (19) |
| Rash | 4 (13) | 2 (6) | 0 | 0 | 6 (19) |
| Anorexia | 4 (13) | 1 (3) | 0 | 0 | 5 (16) |
| Febrile neutropenia | 0 | 1 (3) | 4 (13) | 0 | 5 (16) |
| Cough | 4 (13) | 0 | 0 | 0 | 4 (13) |
| Malaise | 4 (13) | 0 | 0 | 0 | 4 (13) |
| Abdominal pain | 3 (10) | 0 | 0 | 0 | 3 (10) |
| Feeling cold | 3 (10) | 0 | 0 | 0 | 3 (10) |
| Upper respiratory tract infection | 3 (10) | 0 | 0 | 0 | 3 (10) |
| Abdominal pain upper | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Back pain | 1 (3) | 1 (3) | 0 | 0 | 2 (6) |
| Flushing | 1 (3) | 1 (3) | 0 | 0 | 2 (6) |
| Hypokalemia | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Insomnia | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Edema, peripheral | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Pancytopenia | 0 | 0 | 1 (3) | 1 (3) | 2 (6) |
| Tachycardia | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Tremor | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Tumor lysis syndrome | 0 | 0 | 2 (6) | 0 | 2 (6) |
| Hemolytic anemia | 0 | 0 | 1 (3) | 0 | 1 (3) |
| Pneumonitis | 0 | 0 | 1 (3) | 0 | 1 (3) |
| . | Grade . | n (%) . | |||
|---|---|---|---|---|---|
| 1 . | 2 . | 3 . | 4 . | ||
| No. of patients with a study-related event | 2 (6) | 9 (29) | 8 (26) | 12 (39) | 31 (100) |
| Preferred term | |||||
| Nausea | 21 (68) | 6 (19) | 0 | 0 | 27 (87) |
| Pyrexia | 17 (55) | 2 (6) | 1 (3) | 0 | 20 (65) |
| Neutropenia | 0 | 3 (10) | 4 (13) | 12 (39) | 19 (61) |
| Chills | 10 (32) | 5 (16) | 1 (3) | 0 | 16 (52) |
| Vomiting | 10 (32) | 5 (16) | 0 | 0 | 15 (48) |
| Fatigue | 10 (32) | 2 (6) | 1 (3) | 0 | 13 (42) |
| Anemia | 3 (10) | 5 (16) | 2 (6) | 0 | 10 (32) |
| Constipation | 9 (29) | 0 | 1 (3) | 0 | 10 (32) |
| Diarrhea | 9 (29) | 1 (3) | 0 | 0 | 10 (32) |
| Hypotension | 5 (16) | 3 (10) | 0 | 0 | 8 (26) |
| Dyspnea | 4 (13) | 2 (6) | 1 (3) | 0 | 7 (23) |
| Headache | 7 (23) | 0 | 0 | 0 | 7 (23) |
| Leukopenia | 1 (3) | 0 | 4 (13) | 2 (6) | 7 (23) |
| Thrombocytopenia | 0 | 3 (10) | 3 (10) | 1 (3) | 7 (23) |
| Dizziness | 6 (19) | 0 | 0 | 0 | 6 (19) |
| Rash | 4 (13) | 2 (6) | 0 | 0 | 6 (19) |
| Anorexia | 4 (13) | 1 (3) | 0 | 0 | 5 (16) |
| Febrile neutropenia | 0 | 1 (3) | 4 (13) | 0 | 5 (16) |
| Cough | 4 (13) | 0 | 0 | 0 | 4 (13) |
| Malaise | 4 (13) | 0 | 0 | 0 | 4 (13) |
| Abdominal pain | 3 (10) | 0 | 0 | 0 | 3 (10) |
| Feeling cold | 3 (10) | 0 | 0 | 0 | 3 (10) |
| Upper respiratory tract infection | 3 (10) | 0 | 0 | 0 | 3 (10) |
| Abdominal pain upper | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Back pain | 1 (3) | 1 (3) | 0 | 0 | 2 (6) |
| Flushing | 1 (3) | 1 (3) | 0 | 0 | 2 (6) |
| Hypokalemia | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Insomnia | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Edema, peripheral | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Pancytopenia | 0 | 0 | 1 (3) | 1 (3) | 2 (6) |
| Tachycardia | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Tremor | 2 (6) | 0 | 0 | 0 | 2 (6) |
| Tumor lysis syndrome | 0 | 0 | 2 (6) | 0 | 2 (6) |
| Hemolytic anemia | 0 | 0 | 1 (3) | 0 | 1 (3) |
| Pneumonitis | 0 | 0 | 1 (3) | 0 | 1 (3) |
Numbers in parentheses are percentages.
In the last column, a subject was counted only once within each preferred term. Within each preferred term, a subject was counted only once under the worst grade.
Included patients with events with a probably, possibly, or unknown relationship to any study drug.