Summary of safety
| TEAE*, n (% of patients) | Randomised | Non-randomised (n=81) | Overall (n=224) | |
|---|---|---|---|---|
| Arm A (n=66) | Arm B (n=68) | |||
| All TEAEs | 61 (92) | 65 (96) | 72 (89) | 204 (91) |
| SAE | 19 (29) | 25 (37) | 16 (20) | 62 (28) |
| AE leading to withdrawal | 0 | 1 (2) | 3 (4) | 6 (3) |
| SAE leading to withdrawal | 0 | 1 (2) | 1 (1) | 4 (2) |
| Musculoskeletal and connective tissue disorders | ||||
| All | 28 (42) | 35 (52) | 23 (28) | 88 (39) |
| Serious | 6 (9) | 10 (15) | 5 (6) | 22 (10) |
| Gastrointestinal events | ||||
| All | 20 (30) | 18 (27) | 17 (21) | 57 (25) |
| Serious | 0 | 2 (3) | 0 | 2 (1) |
| Cardiac disorders | ||||
| All | 3 (5) | 4 (6) | 2 (3) | 9 (4) |
| Serious | 0 | 0 | 1 (1) | 1 (0.4) |
| Malignancies† | 6 (9) | 1 (2) | 3 (4) | 10 (5) |
| Vascular disorders | ||||
| All | 12 (18) | 6 (9) | 9 (11) | 28 (13) |
| Serious | 2 (3) | 0 | 1 (1) | 3 (1) |
| Infections | ||||
| All | 46 (70) | 40 (59) | 36 (44) | 125 (56) |
| Serious | 8 (12) | 2 (3) | 0 | 10 (5) |
| Overall infection rate/100 PY | 91.4 | 74.1 | 129.4 | 89.1 |
| Serious infection rate/100 PY | 7.0 | 1.7 | 0 | 3.6 |
*Occurring during rituximab (RTX) treatment until 24 weeks after last RTX infusion.
†Benign neoplasms and non-malignant skin cancer excluded.
AE, adverse event; PY, patient-years; RTX, rituximab; SAE, serious adverse event; TEAE, treatment emergency adverse event.