Table 4 Safety profiles in high-risk FL patients (safety population)
AE, n (%) | Bortezomib-rituximab (N=102) | Rituximab (N=98) | ||
|---|---|---|---|---|
Any AE | 97 (95) | 88 (90) | ||
Any related AE | 91 (89) | 64 (65) | ||
Any rituximab-related AE | 70 (69) | 64 (65) | ||
Any bortezomib-related AE | 85 (83) | NA | ||
Any grade ≥3 AE | 52 (51) | 31 (32) | ||
Any serious AE | 22 (22) | 16 (16) | ||
Any related serious AE | 14 (14) | 4 (4) | ||
AE leading to treatment withdrawal | 8 (8) | 2 (2) | ||
Deaths due to AEs | 2 (2) | 1 (1) | ||
Most common AEs | All grades | Grade ≥3 | All grades | Grade ≥3 |
Diarrhea | 50 (49) | 8 (8) | 11 (11) | 0 |
Pyrexia | 30 (29) | 0 | 16 (16) | 1 (1) |
Fatigue | 24 (24) | 1 (1) | 10 (10) | 0 |
Neutropenia | 21 (21) | 18 (18) | 11 (11) | 6 (6) |
Febrile neutropenia | 1 (1) | 1 (1) | 3 (3) | 3 (3) |
Nausea | 19 (19) | 1 (1) | 11 (11) | 0 |
Abdominal pain | 18 (18) | 2 (2) | 9 (9) | 1 (1) |
Decreased appetite | 18 (18) | 0 | 4 (4) | 0 |
Infections | 58 (57) | 16 (16) | 27 (28) | 7 (7) |
Upper respiratory tract | 16 (16) | 3 (3) | 6 (6) | 1 (1) |
Herpes zoster | 16 (16) | 4 (4) | 3 (3) | 1 (1) |
Pneumonia | 6 (6) | 3 (3) | 4 (4) | 3 (3) |
Peripheral edema | 15 (15) | 2 (2) | 13 (13) | 2 (2) |
Asthenia | 15 (15) | 1 (1) | 11 (11) | 4 (4) |
Vomiting | 15 (15) | 0 | 11 (11) | 2 (2) |
Constipation | 15 (15) | 0 | 8 (8) | 0 |
Peripheral sensory neuropathy | 15 (15) | 1 (1) | 0 | 0 |
Dyspnea | 13 (13) | 1 (1) | 10 (10) | 4 (4) |
Anemia | 12 (12) | 4 (4) | 12 (12) | 5 (5) |
Thrombocytopenia | 12 (12) | 5 (5) | 8 (8) | 2 (2) |
Leukopenia | 7 (7) | 3 (3) | 12 (12) | 2 (2) |