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