Table 4

Summary of AEs

Intravenous steroid (%)IFX (%)
Number of patients who experienced an AE54/57 (94.7)54/55 (98.2)
Maximum severity of AE experienced
 Mild5/57 (8.8)10/55 (18.2)
 Moderate40/57 (70.2)31/55 (56.4)
 Severe (including SAEs)9/57 (15.8)13/55 (23.6)
Total number of AEs372369
Total patient-years of follow-up81.979.1
Number of AEs per 100 patient-years454.0466.3
Patient expectation of event
 Expected (listed in PIS)294/372 (79.0)270/369 (73.2)
Severity
 Mild230/372 (61.8)226/369 (61.2)
 Moderate133/372 (35.8)122/369 (33.1)
 Severe (including SAEs)9/372 (2.4)21/369 (5.7)
Relation to study drug
 Not related120/372 (32.3)96/369 (26.0)
 Probably not related160/372 (43.0)197/369 (53.4)
 Possibly related77/372 (20.7)61/369 (16.5)
 Probably related15/372 (4.0)15/369 (4.1)
Number of patients who experienced an SAE9/57 (15.8)13/55 (23.6)
Total number of SAEs920
Number of SAEs per 100 patient-years11.025.3
Relation to study drug
 Not related1/9 (11.1)8/20 (40.0)
 Probably not related6/9 (66.7)7/20 (35.0)
 Possibly related2/9 (22.2)4/20 (20.0)
 Probably related01/20 (5.0)
SAEs by category:
Blood/bone marrow01 in 1/55 patients (1.8)
Cardiac arrhythmia01 in 1/55 patients (1.8)
Cardiac general2 in 2/57 patients (3.5)2 in 1/55 patients (1.8)
Gastrointestinal1 in 1/57 patients (1.8)0
Hepatobiliary/pancreas1 in 1/57 patients (1.8)1 in 1/55 patients (1.8)
Infection—gastrointestinal1 in 1/57 patients (1.8)0
Infection—pulmonary/upper respiratory1 in 1/57 patients (1.8)2 in 2/55 patients (3.6)
Injury, poisoning or procedural complications2 in 2/57 patients (3.5)1 in 1/55 patients (1.8)
Pain—musculoskeletal02 in 2/55 patients (3.6)
Pain—neurology1 in 1/57 patients (1.8)0
Pain—pulmonary/upper respiratory01 in 1/55 patients (1.8)
Pulmonary/upper respiratory04 in 4/55 patients (7.3)
Surgical and medical procedures05 in 5/55 patients (9.1)
  • AE, adverse event; IFX, infliximab + methotrexate; intravenous steroid, intravenous methylprednisolone/placebo + methotrexate; PIS, patient information sheet; SAE, serious AE.