Summary of Safety During the Double-Blind, Placebo-Controlled Periodsa.
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Abbreviations: AE, adverse event; DMARD, disease-modifying antirheumatic drug; IR, inadequate responder; IRR, infusion-related reaction; MTX, methotrexate; OCR200, ocrelizumab 200 mg×2; OCR500, ocrelizumab 500 mg×2; PBO, placebo; TNF, tumor necrosis factor.aMultiple events in individual patients were only counted once. Serious infections were defined as those requiring intravenous antibiotics and/or hospitalization or classified as serious by the investigator. Any opportunistic infection was classified as a serious infection.bAll patients in all studies received background MTX 7.5 to 25 mg/week (7.5 to 20 mg/week in FILM), except for in SCRIPT, in which MTX or leflunomide was permitted.
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2015-12-02



