Summary of safety events during randomized retreatment period. Data are number of patients (%).
Safety Events | Retreatment with Placebo (n = 155) | Retreatment with Rituximab (n = 320) |
---|---|---|
Adverse events | 119 (77) | 226 (71) |
Serious adverse events | 11 (7) | 22 (7) |
Infections | 59 (38) | 120 (38) |
Serious infections | 3 (2) | 7 (2) |
Adverse events leading to withdrawal | 7 (4) | 7 (2) |
Deaths* | 1 (0.6) | 1 (0.3) |
↵* One additional death in rituximab retreatment group after the Week 48 cutoff date.