Table 3.
Safety summary through week 104
| Obinutuzumab n=64 | Placebo n=61 | |
| Any adverse event | 58 (91) | 54 (89) |
| Deaths | 1 (2) | 4 (7) |
| Serious adverse events | 16 (25) | 18 (30) |
| Serious infection adverse events | 5 (8) | 11 (18) |
| Infection adverse event | 48 (75) | 38 (62) |
| Most common adverse events* | ||
| Urinary tract infection | 15 (23) | 13 (21) |
| Bronchitis | 12 (19) | 5 (8) |
| Herpes zoster | 9 (15) | 6 (10) |
| Abdominal pain | 7 (11) | 3 (5) |
| Infusion-related reaction | 7 (11) | 6 (10) |
| Nausea | 6 (9) | 3 (5) |
| Upper respiratory tract infection | 6 (9) | 5 (8) |
| Hypertension | 6 (9) | 3 (5) |
| Anaemia | 5 (8) | 4 (7) |
| Nasopharyngitis | 5 (8) | 6 (10) |
| Pharyngitis | 5 (8) | 4 (7) |
| Arthralgia | 5 (8) | 4 (7) |
| Headache | 5 (8) | 4 (7) |
| Conjunctivitis | 4 (6) | 2 (3) |
| Influenza | 4 (6) | 2 (3) |
| Neutropaenia | 3 (5) | 3 (5) |
| Diarrhoea | 3 (5) | 5 (8) |
| Peripheral oedema | 3 (5) | 3 (5) |
| Gastroenteritis | 3 (5) | 6 (10) |
| Sinusitis | 3 (5) | 0 |
| Insomnia | 3 (5) | 4 (7) |
| Frequent urination | 3 (5) | 0 |
| Cough | 3 (5) | 1 (2) |
| Infusion-related reaction† | 10 (16) | 6 (10) |
| Serious infusion related reaction | 0 | 0 |
| Progressive multifocal leukoencephalopathy | 0 | 1 (2) |
Data are n (%) of patients. One patient randomised to placebo inadvertently received obinutuzumab during the first cycle. This patient is included in the obinutuzumab group for safety analyses.
*Events that occurred in at least 5% of patients in the obinutuzumab group.
†Includes all treatment-related adverse events that occurred in the 24 hours from the start of blinded obinutuzumab or placebo infusions.