virus infections, EBV, CMV PSUR 10 Cumulative Serious thrombo Number of cases data No 70 cytopenia 47,000 pt/yrs PSUR 10 Cumulative Immune haemolytic Number of cases data No 24 anemia 47,000 pt/yrs ISS (RCTs and Moderate to all open label severe plaque trials psoriasis Psoriasis severe forms 3,291 pts candidate for (erythrodermic, Number of cases % 1.4 3.2 systemic pustular) treatment + need” “high subgroup Nervous System PSUR 10 Cumulative disorders including data Inflammatory 47,000 pt/yrs Number of cases No NA polyradiculopathy, Facial Palsy, GBS, Fisher Miller Syndrome Intersticial lung PSUR 10 Cumulative diseases including lung data Number of cases No 18 infiltration, pulmonary 47,000 pt/yrs fibrosis
virus infections, EBV, CMV Serious thrombo cytopenia Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No 70 Immune haemolytic anemia Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No 24 Psoriasis severe forms (erythrodermic, pustular) Number of cases ISS (RCTs and all open label trials 3,291 pts Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup % 1.4 3.2 Nervous System disorders including Inflammatory polyradiculopathy, Facial Palsy, GBS, Fisher Miller Syndrome Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No NA Intersticial lung diseases including lung infiltration, pulmonary fibrosis Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No 18
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