Summary of adverse events
Event . | Total (N = 63) . |
---|---|
Most common adverse events of any grade* | |
Fatigue | 28 (44) |
Diarrhea | 27 (43) |
Anemia | 21 (33) |
Nausea | 16 (25) |
Arthralgia | 15 (24) |
Peripheral edema | 15 (24) |
Thrombocytopenia | 15 (24) |
Cough | 14 (22) |
Dyspnea | 13 (21) |
Upper respiratory tract infection | 13 (21) |
AEs grade ≥3† | |
Anemia | 9 (14) |
Pneumonia | 5 (8) |
Fatigue | 4 (6) |
Cellulitis | 3 (5) |
Diarrhea | 3 (5) |
Hypertension | 3 (5) |
Lymphocyte count decreased | 3 (5) |
Neutropenia | 3 (5) |
Asthenia | 2 (3) |
Autoimmune hemolytic anemia | 2 (3) |
Blood bilirubin increased | 2 (3) |
Muscle spasms | 2 (3) |
Multiple organ dysfunction | 2 (3) |
Neutrophil count decreased | 2 (3) |
Pneumothorax | 2 (3) |
Sepsis | 2 (3) |
Serious AEs‡ | |
Pneumonia | 5 (8) |
Cellulitis | 2 (3) |
Autoimmune hemolytic anemia | 2 (3) |
Pneumothorax | 2 (3) |
Sepsis | 2 (3) |
Event . | Total (N = 63) . |
---|---|
Most common adverse events of any grade* | |
Fatigue | 28 (44) |
Diarrhea | 27 (43) |
Anemia | 21 (33) |
Nausea | 16 (25) |
Arthralgia | 15 (24) |
Peripheral edema | 15 (24) |
Thrombocytopenia | 15 (24) |
Cough | 14 (22) |
Dyspnea | 13 (21) |
Upper respiratory tract infection | 13 (21) |
AEs grade ≥3† | |
Anemia | 9 (14) |
Pneumonia | 5 (8) |
Fatigue | 4 (6) |
Cellulitis | 3 (5) |
Diarrhea | 3 (5) |
Hypertension | 3 (5) |
Lymphocyte count decreased | 3 (5) |
Neutropenia | 3 (5) |
Asthenia | 2 (3) |
Autoimmune hemolytic anemia | 2 (3) |
Blood bilirubin increased | 2 (3) |
Muscle spasms | 2 (3) |
Multiple organ dysfunction | 2 (3) |
Neutrophil count decreased | 2 (3) |
Pneumothorax | 2 (3) |
Sepsis | 2 (3) |
Serious AEs‡ | |
Pneumonia | 5 (8) |
Cellulitis | 2 (3) |
Autoimmune hemolytic anemia | 2 (3) |
Pneumothorax | 2 (3) |
Sepsis | 2 (3) |
Data are presented as n (%) of patients unless indicated otherwise.
The events listed are AEs of any grade that occurred in at least 20% of patients.
The events listed are AEs of grade 3 or higher that occurred in at least 2 patients (3%).
The events listed are serious AEs that occurred in at least 2 patients (3%). The list of all serious AEs is provided in supplemental Table 3.