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Table 3 Number (percent) of patients in the two groups who experienced methotrexate toxicity at any time during the study

From: Comparison of two different folic acid doses with methotrexate – a randomized controlled trial (FOLVARI Study)

Adverse effects/toxicity Folic acid 10 mg per week (FA10) Folic acid 30 mg per week (FA30) P value
N = 47a N = 46a
Undesirable symptoms    
Any undesirable symptom 18 (38.3) 21 (45.7) 0.5
Nausea or vomiting 10 (21.3) 17 (37) 0.1
Dizziness 6 (12.8) 1 (2.2) 0.1
Uneasiness 4 (8.5) 3 (6.5) 1.0
Fatigue 2 (4.3) 3 (6.5) 0.7
Loss of appetite 2 (4.3) 3 (6.5) 0.7
Dysguesia 1 (2.1) 1 (2.2) 1.0
Headache 0 (0) 4 (8.7) 0.06
Oral ulcers 0 (0) 2 (4.4) 0.2
Laboratory abnormalities    
Transaminitis (more than ULN) 20 (42.6) 21 (45.7) 0.7
Transaminitis (more than 2 × ULN) 5 (10.6) 4 (8.7) 1.0
Cytopenia 2 (4.3) 2 (4.4) 0.9
Primary outcomeb 22 (46.8) 25 (54.3) 0.5
Other adverse effects    
Suspected pulmonary toxicity 2 (4.3) 0 (0) 0.5
Herpes zoster 2 (4.3) 1 (2.2) 1.0
  1. Results are presented as number (percent) of patients. aIncluded only those patients who came for at least one follow up visit; bany adverse symptom or cytopenia or transminases elevated more than twice the upper limit of normal (ULN)