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