Table 3 Important ADRs and overtime
Reg. No.1–50001–10001001–20002001–30003001–40004001–5000
Investigated cases500010001000100010001000
Important ADRs
    Bacterial pneumonia108 (2.2%)3014221230
    (Suspected) P jirovecii pneumonia22 (0.4%)61366
    Tuberculosis14 (0.3%)65021
    Interstitial pneumonitis25 (0.5%)45826
    Infusion reactions484 (9.7%)105119998081
    Serious infusion reaction24 (0.5%)78333
Patient characteristics
    History of tuberculosis infection (yes)258 (5.2%)3750534969
    Prophylaxis against tuberculosis (yes)948 (19.0%)135145195219254
    Methotrexate dose (mg/week, mean (SD))7.3 (2.0)7.4 (2.2)7.4 (2.3)7.2 (1.8)7.3 (2.0)7.2 (1.9)
    Concomitant glucocorticosteroid (yes)4,417 (88.3%)925883865874870