Summary of grade 3 or 4 (NCI CTC) AEs that occurred in >5% of cases, according to system organ class (N = 84)
| MedDRA system organ class and AEs, n (%) . | 21/28 (N = 43) . | 28/28 (N = 41) . | Total . |
|---|---|---|---|
| SAEs | 32 (74) | 33 (80) | 65 (77) |
| Study drug related SAEs | 14 (33) | 18 (44) | 32 (38) |
| Any grade 3 and 4 AEs | 40 (93) | 35 (85) | 75 (89) |
| Blood and lymphatic system disorders | 32 (74) | 30 (73) | 62 (74) |
| Anemia | 16 (37) | 14 (34) | 30 (36) |
| Neutropenia | 28 (65) | 24 (58.5) | 52 (62) |
| Thrombocytopenia | 12 (28) | 11 (27) | 23 (27) |
| General disorders and administration site conditions | 10 (23) | 10 (24) | 20 (24) |
| Asthenia | 6 (14) | 2 (5) | 8 (9.5) |
| Infections and infestations | 8 (19) | 11 (27) | 19 (23) |
| Pneumonia | 3 (7) | 8 (19.5) | 11 (13) |
| Musculoskeletal and connective tissue disorders | 9 (21) | 8 (19.5) | 17 (20) |
| Bone pain | 6 (14) | 3 (7) | 9 (11) |
| Renal and urinary disorders | 7 (16) | 2 (5) | 9 (11) |
| Renal failure | 7 (16) | 2 (5) | 9 (11) |
| Respiratory disorders | 8 (19) | 2 (5) | 10 (12) |
| Dyspnea | 5 (12) | 0 | 5 (6) |
| MedDRA system organ class and AEs, n (%) . | 21/28 (N = 43) . | 28/28 (N = 41) . | Total . |
|---|---|---|---|
| SAEs | 32 (74) | 33 (80) | 65 (77) |
| Study drug related SAEs | 14 (33) | 18 (44) | 32 (38) |
| Any grade 3 and 4 AEs | 40 (93) | 35 (85) | 75 (89) |
| Blood and lymphatic system disorders | 32 (74) | 30 (73) | 62 (74) |
| Anemia | 16 (37) | 14 (34) | 30 (36) |
| Neutropenia | 28 (65) | 24 (58.5) | 52 (62) |
| Thrombocytopenia | 12 (28) | 11 (27) | 23 (27) |
| General disorders and administration site conditions | 10 (23) | 10 (24) | 20 (24) |
| Asthenia | 6 (14) | 2 (5) | 8 (9.5) |
| Infections and infestations | 8 (19) | 11 (27) | 19 (23) |
| Pneumonia | 3 (7) | 8 (19.5) | 11 (13) |
| Musculoskeletal and connective tissue disorders | 9 (21) | 8 (19.5) | 17 (20) |
| Bone pain | 6 (14) | 3 (7) | 9 (11) |
| Renal and urinary disorders | 7 (16) | 2 (5) | 9 (11) |
| Renal failure | 7 (16) | 2 (5) | 9 (11) |
| Respiratory disorders | 8 (19) | 2 (5) | 10 (12) |
| Dyspnea | 5 (12) | 0 | 5 (6) |