Table 2.
Adverse drug reaction profile based on MTX dose
| MTX dosage groups at baseline | Total | Total | High dose (≥8 mg/week) | Low dose (<8 mg/week) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| MTX dosage groups at week 24 | n = 157 | High dose n = 66 | Low dose n = 2 | High dose n = 43 | Low dose n = 30 | ||||||
| Non-serious | Serious | Non-serious | Serious | Non-serious | Serious | Non-serious | Serious | Non-serious | Serious | ||
| No. of ADR onset cases | 25 | 4 | 29 | 7 | 0 | 2 | 0 | 9 | 1 | 2 | 1 |
| No. of ADRs | 32 | 5 | 37 | 9 | 0 | 2 | 0 | 13 | 2 | 3 | 1 |
| Incidence of ADRs, % | 16.3 | 2.6 | 18.5 | 11.1 | 0 | 100 | 0 | 20.9 | 2.3 | 6.9 | 3.4 |
| Infectious and parasitic diseases | 7 | 2 | 9 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 1 |
| Gastroenteritis | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nasopharyngitis | 2 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Pyelonephritis | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Herpes zoster | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Pulpitis dental | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pneumonia | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pneumonia bacterial | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pneumocystis jiroveci pneumonia | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Immune system disorders | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypersensitivity | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Psychiatric disorder | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Dysphoria | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Cardiac disorder | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Pericarditis | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Interstitial lung disease | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pleurisy | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Skin and subcutaneous tissue disorders | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Alopecia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pruritus | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Rash | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Musculoskeletal and connective tissue disorder | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Arthralgia | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Gastrointestinal disorder | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| General disorders and administration site conditions | 4 | 0 | 4 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Injection site reaction | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chills | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Pyrexia | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Injection site erythema | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Peripheral edema | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Event that cannot be evaluated | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Laboratory tests | 10 | 0 | 10 | 4 | 0 | 2 | 0 | 3 | 0 | 1 | 0 |
| Increase in alanine aminotransferase | 2 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Increase in aspartate aminotransferase | 2 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Decrease in white blood cell count | 2 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Abnormal liver function test | 3 | 0 | 3 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Elevation of liver enzyme | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abnormal liver enzymes | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Increase in β-d-glucan in the blood | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Decrease in blood platelet count | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
ADR adverse drug reaction, MTX methotrexate