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Risk of cardiotoxicity with prior and/or concomitant Methotrexate therapy. Cardiac events includes patients with reported cardiac SAEs, with signs or symptoms of CHF requiring hospitalization or other therapy, with an LVEF decrease to 50% of baseline, or with a clinically significant drop in LVEF as indicated by a 10% decrease from baseline. CHF=congestive heart failure; LVEF=left ventricular ejection fraction; MTX=Methotrexate; SAE=serious adverse event.
