ADVERSE EFFECTS The most common adverse drug reactions observed in the multinational, open label, Phase 3 clinical study (incidence for ELOCTATE were arthralgia and malaise. ≥1%) No serious adverse drug reactions were reported in subjects who received ELOCTATE. In the multinational, open-label, Phase 3 clinical study with ELOCTATE, 164 subjects were evaluated, with 146 subjects treated for at least 26 weeks and 23 subjects treated for at least 39 weeks. Adverse drug reactions (ADRs) were reported in 9 of 164 (5.5%) subjects treated with routine prophylaxis or episodic (on-demand) therapy. Adverse drug reactions are considered adverse events assessed as related to treatment with ELOCTATE. Adverse drug reactions are summarised in 9. One (1) subject was withdrawn from due to an adverse drug reaction of rash. In the study, no inhibitors were detected and no events of anaphylaxis were reported. Table 9: Adverse Drug Reactions reported for ELOCTATE N=164* MedDRA2 MedDRA Number Frequency Category3 System Organ Preferred Term of Class Common Uncommon Subjects (≥1/100 to <1/10) (≥1/1,000 to <1/100) n (%) General Malaise 2 (1.2) Common disorders and Chest pain 1 (0.6) Uncommon Feeling cold 1 (0.6) Uncommon administration site conditions Feeling hot 1 (0.6) Uncommon Nervous system Dizziness 1 (0.6) Uncommon disorders Dysgeusia 1 (0.6) Uncommon Headache 1 (0.6) Uncommon Arthralgia 2 (1.2) Common Musculoskeletal disorders Joint swelling 1 (0.6) Uncommon Myalgia 1 (0.6) Uncommon Gastrointestinal Abdominal pain, 1 (0.6) Uncommon disorders lower Abdominal pain, 1 (0.6) Uncommon upper Angiopathy1 1 (0.6) Uncommon Vascular disorders Hypertension 1 (0.6) Uncommon Cardiac disorders Bradycardia 1 (0.6) Uncommon Injury, poisoning, Procedural 1 (0.6) Uncommon and procedural hypotension complications
ADVERSE EFFECTS The most common adverse drug reactions observed in the multinational, open label, Phase 3 clinical study (incidence ≥1%) for ELOCTATE were arthralgia and malaise. No serious adverse drug reactions were reported in subjects who received ELOCTATE. In the multinational, open-label, Phase 3 clinical study with ELOCTATE, 164 subjects were evaluated, with 146 subjects treated for at least 26 weeks and 23 subjects treated for at least 39 weeks. Adverse drug reactions (ADRs) were reported in 9 of 164 (5.5%) subjects treated with routine prophylaxis or episodic (on-demand) therapy. Adverse drug reactions are considered adverse events assessed as related to treatment with ELOCTATE. Adverse drug reactions are summarised in 9. One (1) subject was withdrawn from due to an adverse drug reaction of rash. In the study, no inhibitors were detected and no events of anaphylaxis were reported. Table 9: Adverse Drug Reactions reported for ELOCTATE MedDRA2 System Organ Class MedDRA Preferred Term N=164* Number of Subjects n (%) Frequency Category3 Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) General disorders and administration site conditions Malaise Chest pain Feeling cold Feeling hot 2 (1.2) 1 (0.6) 1 (0.6) 1 (0.6) Common Uncommon Uncommon Uncommon Nervous system disorders Dizziness Dysgeusia Headache 1 (0.6) 1 (0.6) 1 (0.6) Uncommon Uncommon Uncommon Musculoskeletal disorders Arthralgia Joint swelling Myalgia 2 (1.2) 1 (0.6) 1 (0.6) Common Uncommon Uncommon Gastrointestinal disorders Abdominal pain, lower Abdominal pain, upper 1 (0.6) 1 (0.6) Uncommon Uncommon Vascular disorders Angiopathy1 Hypertension 1 (0.6) 1 (0.6) Uncommon Uncommon Cardiac disorders Bradycardia 1 (0.6) Uncommon Injury, poisoning, and procedural complications Procedural hypotension 1 (0.6) Uncommon
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