Table 2 Any AEs in ≥2% (grade ≥ 3) of patients by haematologic toxicity and infections.
All Grade | Grade ≥ 3 | |||
|---|---|---|---|---|
Preferred term | Ofatumumab (n = 239) | Observation (n = 241) | Ofatumumab (n = 239) | Observation (n = 241) |
Any event, n (%) | 209 (87) | 168 (70) | 105 (44) | 74 (31) |
Haematologic toxicity, n (%) | ||||
Neutropenia | 64 (27) | 27 (11) | 56 (23) | 24 (10) |
Febrile neutropenia | 17 (7) | 11 (5) | 14 (6%) | 9 (4%) |
Thrombocytopenia | 14 (6) | 15 (6) | 5 (2) | 8 (3) |
Anaemia | 9 (4) | 15 (6) | 5 (2) | 7 (3) |
Neutrophil count decreased | 8 (3) | 3 (1) | 5 (2) | 2 (<1) |
Infections, n (%) | ||||
Pneumonia | 42 (18) | 41 (17) | 32 (13) | 28 (12) |
Pyrexia | 51 (21) | 31 (13) | 12 (5) | 6 (2) |
Sepsis | 7 (3) | 5 (2) | 7 (3) | 5 (2) |
Septic shock | 5 (2) | 1 (<1) | 5 (2) | 1 (<1) |
Lung infection | 4 (2) | 4 (2) | 4 (2) | 3 (1) |
Upper respiratory tract infection | 54 (23) | 28 (12) | 4 (2) | 1 (<1) |
Herpes zoster | 17 (7) | 12 (5) | 3 (1) | 4 (2) |
Urinary tract infection | 13 (5) | 12 (5) | 2 (<1) | 5 (2) |
Cellulitis | 5 (2) | 5 (2) | 2 (<1) | 4 (2) |
Respiratory tract infection | 18 (8) | 18 (7) | 2 (<1) | 4 (2) |
Infusion-related reaction, n (%) | 42 (18) | 0 | 3 (1) | 0 |
