Number (%) of patients experiencing adverse events during the trial
| Adverse events | Treatment group | |
|---|---|---|
| FIN-RACo+infliximab (n=50) | FIN-RACo+placebo (n=49) | |
| N (%) | N (%) | |
| Any adverse event | 45 (90) | 47 (96) |
| Gastrointestinal | 28 (56) | 30 (61) |
| Mucocutaneous | 21 (42) | 18 (37) |
| Respiratory | 28 (56) | 33 (67) |
| Central nervous system | 9 (18) | 8 (16) |
| Elevated liver enzymes | 6 (12) | 8 (16) |
| Urogenital | 8 (16) | 11 (22) |
| Cardiovascular | 6 (12) | 8 (16) |
| Other | 25 (50) | 29 (59) |
| Change of DMARD due to adverse event | 15 (30) | 12 (24) |
| Serious adverse event* | 3 (6) | 4 (8) |
| Pneumonia† | 0 | 2 |
| Suspected septic arthritis‡ | 1 | 0 |
| Gastroenteritis§ | 0 | 1 |
| Atypical mycobacteria infection¶ | 1 | 0 |
| Methotrexate pneumonitis‡ | 1 | 0 |
| Benign ovarian cyst** | 0 | 1 |
| Agranulocytosis†† | 0 | 1 |
| Sudden death (CHD)‡‡ | 1 | 0 |
*Necessitating hospital admission, life-threatening, fatal or malignancy.
†Varicella pneumonia at 5 months; pneumonia at 12 months.
‡At 8 months.
§At 9 months.
¶At 3 months.
**At 15 months.
††At 6 weeks.
‡‡At 17 months.
CHD, coronary heart disease; DMARD, disease-modifying antirheumatic drug.