AEs, AEs ≥grade 3 and serious AEs, and AEs of special interest
| Preferred term . | Ofatumumab (n = 217) . | Rituximab (n = 218) . |
|---|---|---|
| AEs (≥10% in either arm), n (%) | ||
| Any event | 202 (93) | 183 (84) |
| Infusion-related reaction | 45 (21) | 19 (9) |
| Rash | 42 (19) | 11 (5) |
| Urticaria | 41 (19) | 3 (1) |
| Fatigue | 21 (10) | 29 (13) |
| Diarrhea | 21 (10) | 15 (7) |
| Nasopharyngitis | 14 (6) | 22 (10) |
| White blood cell count decreased | 12 (6) | 23 (11) |
| Pyrexia | 9 (4) | 22 (10) |
| AEs ≥ grade 3 (≥5% of patients), n (%) | ||
| Any event | 81 (37) | 60 (28) |
| Urticaria | 16 (7) | 0 (0) |
| Infusion-related reaction | 11 (5) | 0 (0) |
| Neutropenia | 4 (2) | 12 (6) |
| Serious AEs (≥1% of patients), n (%) | ||
| Any event | 38 (18) | 37 (17) |
| Infusion-related reaction | 5 (2) | 0 (0) |
| Pneumonia | 2 (< 1) | 5 (2) |
| Sepsis | 1 (< 1) | 3 (1) |
| AEs of special interest (≥1% of patients), n (%) | ||
| Infusion-related AEs | 178 (82) | 112 (51) |
| Infection-related AEs | 69 (32) | 81 (37) |
| Cardiac events | 15 (7) | 8 (4) |
| Neoplasms | 13 (6) | 7 (3) |
| Muco-cutaneous reactions | 125 (58) | 49 (22) |
| Tumor lysis syndrome | 3 (1) | 0 (0) |
| Preferred term . | Ofatumumab (n = 217) . | Rituximab (n = 218) . |
|---|---|---|
| AEs (≥10% in either arm), n (%) | ||
| Any event | 202 (93) | 183 (84) |
| Infusion-related reaction | 45 (21) | 19 (9) |
| Rash | 42 (19) | 11 (5) |
| Urticaria | 41 (19) | 3 (1) |
| Fatigue | 21 (10) | 29 (13) |
| Diarrhea | 21 (10) | 15 (7) |
| Nasopharyngitis | 14 (6) | 22 (10) |
| White blood cell count decreased | 12 (6) | 23 (11) |
| Pyrexia | 9 (4) | 22 (10) |
| AEs ≥ grade 3 (≥5% of patients), n (%) | ||
| Any event | 81 (37) | 60 (28) |
| Urticaria | 16 (7) | 0 (0) |
| Infusion-related reaction | 11 (5) | 0 (0) |
| Neutropenia | 4 (2) | 12 (6) |
| Serious AEs (≥1% of patients), n (%) | ||
| Any event | 38 (18) | 37 (17) |
| Infusion-related reaction | 5 (2) | 0 (0) |
| Pneumonia | 2 (< 1) | 5 (2) |
| Sepsis | 1 (< 1) | 3 (1) |
| AEs of special interest (≥1% of patients), n (%) | ||
| Infusion-related AEs | 178 (82) | 112 (51) |
| Infection-related AEs | 69 (32) | 81 (37) |
| Cardiac events | 15 (7) | 8 (4) |
| Neoplasms | 13 (6) | 7 (3) |
| Muco-cutaneous reactions | 125 (58) | 49 (22) |
| Tumor lysis syndrome | 3 (1) | 0 (0) |