Table 3 Adverse reactions reported with Praluent in pooled controlled studies System Common Rare Organ Class Immune hypersensitivity system hypersensitivity disorders vasculitis Respiratory, Upper thoracic and respiratory mediastinal tract signs disorders and symptoms* Skin and Pruritus urticaria subcutaneous eczema tissue nummular disorders General Injection disorders and site administration reactions** site conditions * including mainly oropharyngeal pain, rhinorrhea, sneezing ** including erythema/redness, itching, swelling, pain/tenderness Table 4 shows the adverse events reported in of patients treated with alirocumab and more ≥1% frequently than with placebo in pooled placebo-controlled studies. Table 4 Adverse events occurring in of patients treated with alirocumab and more frequently ≥1% than with placebo in the pool of placebo-controlled trials Primary System Organ Class Placebo Alirocumab Preferred Term n(%) (N=1276) (N=2476) Infections and infestations Nasopharyngitis 11.1% 11.3%
Table 3 Adverse reactions reported with Praluent in pooled controlled studies System Organ Class Common Rare Immune system disorders hypersensitivity hypersensitivity vasculitis Respiratory, thoracic and mediastinal disorders Upper respiratory tract signs and symptoms* Skin and subcutaneous tissue disorders Pruritus urticaria eczema nummular General disorders and administration site conditions Injection site reactions** * including mainly oropharyngeal pain, rhinorrhea, sneezing ** including erythema/redness, itching, swelling, pain/tenderness Table 4 shows the adverse events reported in ≥1% of patients treated with alirocumab and more frequently than with placebo in pooled placebo-controlled studies. Table 4 Adverse events occurring in ≥1% of patients treated with alirocumab and more frequently than with placebo in the pool of placebo-controlled trials Primary System Organ Class Preferred Term n(%) Placebo (N=1276) Alirocumab (N=2476) Infections and infestations Nasopharyngitis 11.1% 11.3%