Table 2.
Total number and incidence rate of safety events (serious adverse events [SAEs] and non-serious adverse events of special interest [AESIs]) and SAEs by event category for rituximab and control groups
| Rituximab (N = 247) |
Control (N = 145) |
Rituximab (N = 247) | Control (N = 145) | |||
|---|---|---|---|---|---|---|
| Event type | Events n | Patients n (%) | Events n | Patients n (%) | IR per 1000 person-years (95% CI)a | IR per 1000 person-years (95% CI)a |
| All safety events | 533 | 164 (66%) | 170 | 78 (54%) | 373.3 (342.9, 406.4) | 192.1 (165.3, 223.2) |
| Infection | 124 | 67 (27%) | 29 | 19 (13%) | 86.9 (72.8, 103.6) | 32.8 (22.8, 47.2) |
| Cardiovascular disorder | 42 | 36 (15%) | 22 | 18 (12%) | 29.4 (21.7, 39.8) | 24.9 (16.4, 37.8) |
| Haematological events | 35 | 31 (13%) | 9 | 9 (6%) | 24.5 (17.6, 34.1) | 10.2 (5.3, 19.5) |
| Malignant events | 28 | 21 (9%) | 21 | 16 (11%) | 19.6 (13.5, 28.4) | 23.7 (15.5, 36.4) |
| Renal Insufficiency | 21 | 15 (6%) | 20 | 15 (10%) | 14.7 (9.6, 22.6) | 22.6 (14.6, 35) |
| PML | 1 | 1 (0.4%) | 0 | 0 (0%) | 0.7 (0.1, 5) | 0 (0, NaN) |
| Additional safety events | 282 | 122 (49%) | 69 | 48 (33%) | 197.5 (175.8, 222) | 78.0 (61.6, 98.7) |
| All SAEs | 386 | 134 (54%) | 114 | 58 (40%) | 270.4 (244.7, 298.7) | 128.8 (107.2, 154.8) |
| Serious infection | 121 | 65 (26%) | 28 | 18 (12%) | 84.8 (70.9, 101.3) | 31.6 (21.8, 45.8) |
| Cardiovascular disorder | 28 | 23 (9%) | 17 | 15 (10%) | 19.6 (13.5, 28.4) | 19.2 (11.9, 30.9) |
| Haematological events | 9 | 8 (3%) | 2 | 2 (1%) | 6.3 (3.3, 12.1) | 2.3 (0.6, 9.0) |
| Malignant events | 11 | 11 (4%) | 8 | 8 (6%) | 7.7 (4.3, 13.9) | 9.0 (4.5, 18.1) |
| Renal Insufficiency | 19 | 14 (6%) | 19 | 15 (10%) | 13.3 (8.5, 20.9) | 21.5 (13.7, 33.7) |
| PML | 1 | 1 (0.4%) | 0 | 0 (0%) | 0.7 (0.1, 5) | 0 (0, NaN) |
| Additional safety eventsb | 197 | 95 (38%) | 40 | 30 (21%) | 138.0 (120, 158.7) | 45.2 (33.2, 61.6) |
a
Total follow-up period was 1369.7 per 1000 person-years for the rituximab and 847.8 per 1000 person-years for the control group.
b
Additional safety events include hypogammaglobulinemia (<3 g/l) requiring treatment or change of treatment, hypogammaglobulinemia requiring Ig replacement therapy, serious disease flares (major flare), serious infusion-related reaction, vaccination failure, and any other SAEs of unclear categorization.
IR: incidence rate; PML: progressive multifocal leukoencephalopathy.