Table 3.
Most common drug-related AEs
| Patients with events, n (%) | Part 1 MR (n= 13) | Part 2 MRV (n= 32) | Total (N= 45) |
|---|---|---|---|
| Any-grade drug-related AEs occurring in ≥10% of patients overall | |||
| Neutropenia | 7 (54) | 14 (44) | 21 (47) |
| Leukopenia | 8 (62) | 11 (34) | 19 (42) |
| Anemia | 4 (31) | 13 (41) | 17 (38) |
| Diarrhea | 4 (31) | 11 (34) | 15 (33) |
| Thrombocytopenia | 7 (54) | 8 (25) | 15 (33) |
| Fatigue | 3 (23) | 11 (34) | 14 (31) |
| Alopecia | 3 (23) | 6 (19) | 9 (20) |
| Nausea | 1 (8) | 8 (25) | 9 (20) |
| Stomatitis | 2 (15) | 7 (22) | 9 (20) |
| Respiratory, thoracic, and mediastinal disorders SOC | 2 (15) | 5 (16) | 7 (16) |
| Decreased appetite | 0 | 6 (19) | 6 (13) |
| Febrile neutropenia | 0 | 6 (19) | 6 (13) |
| Infections and infestations | 1 (8) | 5 (16) | 6 (13) |
| Lymphopenia | 2 (15) | 4 (13) | 6 (13) |
| Constipation | 1 (8) | 4 (13) | 5 (11) |
| Decreased neutrophil count | 1 (8) | 4 (13) | 5 (11) |
| Peripheral neuropathy | 0 | 5 (16) | 5 (11) |
| Musculoskeletal and connective tissue disorders SOC | 1 (8) | 4 (13) | 5 (11) |
| Vomiting | 1 (8) | 4 (13) | 5 (11) |
| Drug-related grade ≥3 AEs occurring in >1 patient | |||
| Neutropenia | 7 (54) | 12 (38) | 19 (42) |
| Leukopenia | 8 (62) | 8 (25) | 16 (36) |
| Anemia | 4 (31) | 6 (19) | 10 (22) |
| Thrombocytopenia | 3 (23) | 6 (19) | 9 (20) |
| Febrile neutropenia | 0 | 6 (19) | 6 (13) |
| Decreased neutrophil count | 1 (8) | 4 (13) | 5 (11) |
| Lymphopenia | 2 (15) | 2 (6) | 4 (9) |
| Stomatitis | 0 | 4 (13) | 4 (9) |
| Fatigue | 1 (8) | 2 (6) | 3 (7) |
| Decreased platelet count | 0 | 2 (6) | 2 (4) |
| Palmar-plantar erythrodysesthesia syndrome | 0 | 2 (6) | 2 (4) |
Abbreviations: AE, adverse event; MR, alisertib plus rituximab; MRV, alisertib plus rituximab plus vincristine; SOC, system organ class.