Table 2: Adverse Events

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)