| Assessment | Group 1 | Group 2 | Group 3 | Group 4 | ||||
| Placebo + methotrexate (n = 134) | Golimumab 100 mg + placebo (n = 133) | Golimumab 50 mg + methotrexate (n = 212) | Golimumab 100 mg + methotrexate (n = 105) | |||||
| n (%) | Events per patient-year | n (%) | Events per patient-year | n (%) | Events per patient-year | n (%) | Events per patient-year | |
| Any adverse event | 89 (66.4%) | 4.72 (4.16 to 5.33) | 98 (73.7%) | 2.74 (2.45 to 3.05) | 87 (41.0%) | 1.75 (1.53 to 1.99) | 78 (74.3%) | 2.82 (2.48 to 3.19) |
| Serious adverse events | 5 (3.7%) | 0.09 (0.03 to 0.21) | 8 (6.0%) | 0.11 (0.06 to 0.19) | 9 (4.2%) | 0.08 (0.04 to 0.14) | 13 (12.4%) | 0.18 (0.10 to 0.30) |
| Any infection | 37 (27.6%) | 1.16 (0.89 to 1.48) | 50 (37.6%) | 0.71 (0.57 to 0.88) | 34 (16.0%) | 0.36 (0.27 to 0.48) | 39 (37.1%) | 0.79 (0.62 to 1.00) |
| Serious infections | 1 (0.7%) | 0.02 (<0.01 to 0.10) | 4 (3.0%) | 0.05 (0.02 to 0.11) | 2 (0.9%) | 0.02 (<0.01 to 0.06) | 5 (4.8%) | 0.08 (0.03 to 0.17) |
| Cellulitis | 0 (0.0%) | 0.00 (0.00 to 0.06) | 0 (0.0%) | 0.00 (0.00 to 0.03) | 1 (0.5%) | 0.01 (<0.01 to 0.04) | 1 (1.0%) | 0.01 (<0.01 to 0.06) |
| Sepsis | 0 (0.0%) | 0.00 (0.00 to 0.06) | 2 (1.5%) | 0.02 (<0.01 to 0.06) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 2 (1.9%) | 0.02 (<0.01 to 0.08) |
| UTI | 1 (0.7%) | 0.02 (<0.01 to 0.10) | 0 (0.0%) | 0.00 (0.00 to 0.03) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 2 (1.9%) | 0.02 (<0.01 to 0.08) |
| Bacterial arthritis | 0 (0.0%) | 0.00 (0.00 to 0.06) | 0 (0.0%) | 0.00 (0.00 to 0.03) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 1 (1.0%) | 0.01 (<0.01 to 0.06) |
| Lower RTI | 0 (0.0%) | 0.00 (0.00 to 0.06) | 0 (0.0%) | 0.00 (0.00 to 0.03) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 1 (1.0%) | 0.01 (<0.01 to 0.06) |
| SC abscess | 0 (0.0%) | 0.00 (0.00 to 0.06) | 0 (0.0%) | 0.00 (0.00 to 0.03) | 1 (0.5%) | 0.01 (<0.01 to 0.04) | 0 (0.0%) | 0.00 (0.00 to 0.03) |
| Colitis | 0 (0.0%) | 0.00 (0.00 to 0.06) | 1 (0.8%) | 0.01 (<0.01 to 0.05) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 0 (0.0%) | 0.00 (0.00 to 0.03) |
| Diarrhoea | 0 (0.0%) | 0.00 (0.00 to 0.06) | 1 (0.8%) | 0.01 (<0.01 to 0.05) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 0 (0.0%) | 0.00 (0.00 to 0.03) |
| Infective arthritis | 0 (0.0%) | 0.00 (0.00 to 0.06) | 1 (0.8%) | 0.01 (<0.01 to 0.05) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 0 (0.0%) | 0.00 (0.00 to 0.03) |
| Skin laceration | 0 (0.0%) | 0.00 (0.00 to 0.06) | 1 (0.8%) | 0.01 (<0.01 to 0.05) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 0 (0.0%) | 0.00 (0.00 to 0.03) |
| Injection-site reactions | 4 (3.0%) | 0.11 (0.04 to 0.24) | 10 (7.5%) | 0.12 (0.06 to 0.20) | 5 (2.4%) | 0.08 (0.04 to 0.14) | 5 (4.8%) | 0.07 (0.03 to 0.15) |
| Malignancies | 1 (0.7%) | 0.02 (<0.01 to 0.10) | 2 (1.5%) | 0.02 (<0.01 to 0.06) | 0 (0.0%) | 0.00 (0.00 to 0.02) | 1 (1.0%) | 0.01 (<0.01 to 0.06) |
Values are n (%) of patients having an event or number of events per patient year (95% CI). Events were categorised by the actual treatment the patient was receiving at the time of the event. Total numbers of patients in each column are the numbers of patients who received that treatment at any time to week 24. Therefore, patients who entered early escape were counted in more than one column. RTI, respiratory tract infection; SC, subcutaneous; UTI, urinary tract infection.