Table 3

Number (%) of patients experiencing adverse events during the trial

Adverse eventsTreatment group
FIN-RACo+infliximab (n=50)FIN-RACo+placebo (n=49)
N (%)N (%)
Any adverse event45 (90)47 (96)
 Gastrointestinal28 (56)30 (61)
 Mucocutaneous21 (42)18 (37)
 Respiratory28 (56)33 (67)
 Central nervous system9 (18)8 (16)
 Elevated liver enzymes6 (12)8 (16)
 Urogenital8 (16)11 (22)
 Cardiovascular6 (12)8 (16)
 Other25 (50)29 (59)
 Change of DMARD due to adverse event15 (30)12 (24)
Serious adverse event*3 (6)4 (8)
 Pneumonia†02
 Suspected septic arthritis‡10
 Gastroenteritis§01
 Atypical mycobacteria infection¶10
 Methotrexate pneumonitis‡10
 Benign ovarian cyst**01
 Agranulocytosis††01
 Sudden death (CHD)‡‡10
  • *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.