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Table 4 Safety profiles in high-risk FL patients (safety population)

From: Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naïve or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial

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)
  1. AE, adverse event; NA, not applicable.
  2. Table includes the most commonly reported AEs (≥15% at any grade or ≥3% grade ≥ 3 in either arm).