Table 3 Patients with adverse events (AEs) and serious adverse events (SAEs)
|  | Total n = 90 | IFX + MTX n = 38 | MTX n = 36 | PL n = 16 |
|---|---|---|---|---|
Adverse events, n (%) | Â | Â | Â | Â |
 Infectious/parasitic disease | 31 (35%) | 19 (50%) | 9 (25%) | 3 (19%) |
 Malignancy | 1 (1%) | 0 | 1 (3%) | 0 |
 Disease of blood, blood-forming organs, and immune mechanisms (except arthritis) | 1 (1%) | 1 (3%) | 0 | 0 |
 Endocrine, nutritional, and metabolic diseases | 9 (10%) | 2 (5%) | 5 (14%) | 2 (12%) |
 Disease of the nervous system | 17 (19%) | 6 (16%) | 9 (25%) | 2 (13%) |
 Diseases of the eye | 3 (3%) | 1 (3%) | 2 (6%) | 0 |
 Diseases of circulatory system | 16 (18%) | 6 (16%) | 7 (19%) | 3 (19%) |
 Diseases of respiratory system | 43 (48%) | 23 (61%) | 16 (44%) | 4 (25%) |
 Diseases of the digestive system | 37 (41%) | 15 (39%) | 17 (47%) | 5 (31%) |
 Diseases of the skin and subcutaneous tissue | 25 (28%) | 12 (32%) | 8 (22%) | 5 (31%) |
 Diseases of musculoskeletal system and connective tissue | 30 (33%) | 15 (39%) | 9 (25%) | 6 (38%) |
 Diseases of urogenital system (pregnancy, childbirth, and puerperium) | 4 (4%) | 2 (5%) | 2 (6%) | 0 |
 Symptoms, signs, and abnormal clinical and laboratory findings not elsewhere classified | 27 (30%) | 11 (29%) | 11 (31%) | 5 (31%) |
 Injury, poisoning and certain other consequences of external causes | 9 (10%) | 6 (16%) | 3 (8%) | 0 |
 External causes of morbidity | 1 (1%) | 1 (3%) | 0 | 0 |
 Total |  | 120 | 99 | 35 |
SAEs (n = 12) | ||||
 Hospitalisation due to different reasonsa | 4 | 1 | 3 | |
 Fainted during blood collection prior to administration of study drug | 1 | 0 | 0 | |
 Significantly raised transaminase levels | 1 | 0 | 0 | |
 Hematuria, followed by a diagnosis of bladder cancer | 0 | 1 | 0 | |
 Hypertensive episode 1 h after the last infusion with study drug | 0 | 1 | 0 | |