MedDRA System Organ Class/Preferred Terms | MTX Medium Concentration n=131 n (%) |
MTX High Concentration n=131 n (%) |
Total n=131 n (%) |
---|---|---|---|
Number or patients with adverse events | 14 (10.7) | 15 (11.5) | 25 (19.1) |
Gastrointestinal disorders | 5 (3.8) | 4 (3.1) | 8 (6.1) |
Abdominal pain | 0 (0.0) | 2 (1.5) | 2 (1.5) |
Abdominal pain upper | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Diarrhoea | 2 (1.5) | 0 (0.0) | 2 (1.5) |
Mouth ulceration | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Nausea | 3 (2.3) | 1 (0.8) | 4 (3.1) |
Investigations | 0 (0.0) | 5 (3.8) | 5 (3.8) |
Alanine aminotransferase increased | 0 (0.0) | 5 (3.8) | 5 (3.8) |
Aspartate aminotransferase increased | 0 (0.0) | 2 (1.5) | 2 (1.5) |
Gamma-glutamyltransferase increased | 0 (0.0) | 1 (0.8) | 1 (0.8) |
White blood cell count decreased | 0 (0.0) | 1 (0.8) | 0 (0.0) |
General disorders and administration site conditions | 3 (2.3) | 2 (1.5) | 4 (3.1) |
Fatigue | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Feeling abnormal | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Injection site irritation | 1 (0.8) | 1 (0.8) | 1 (0.8) |
Mucosal dryness | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Pain | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Skin and subcutaneous tissue disorders | 2 (1.5) | 1 (0.8) | 3 (2.3) |
Alopecia | 2 (1.5) | 0 (0.0) | 2 (1.5) |
Erythema | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Musculoskeletal and connective tissue disorders | 1 (0.8) | 2 (1.5) | 2 (1.5) |
Musculoskeletal pain | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Myalgia | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Pain in extremity | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Rheumatoid arthritis (worsening) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Nervous system disorders | 1 (0.8) | 1 (0.8) | 2 (1.5) |
Cervical root pain | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Dizziness | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Respiratory, thoracic and mediastinal disorders/ Cough | 2 (1.5) | 0 (0.0) | 2 (1.5) |
Infections and infestations/Oral herpes | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Ear and labyrinth disorders/Vertigo | 0 (0.0) | 1 (0.8) | 1 (0.8) |
Injury, poisoning and procedural complications/Facial bones fracture | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Metabolism and nutrition disorders/Anorexia | 1 (0.8) | 0 (0.0) | 1 (0.8) |
Vascular disorders Extremity necrosis | 1 (0.8) | 0 (0.0) | 1 (0.8) |