Nervous system Headache 14 8 disorders Vascular disorders Hypertension 6 3 Flushing 2 1 Page 1 of 2 Footnotes defined on next page of the table Table 33. Adverse Reactions Reported by Patients Treated With Adalimumab during Placebo-Controlled Period of Rheumatoid Arthritis Studies Adalimumab Control (n=1380) (n=690) System Organ Classa) Adverse Reactiona) % % Respiratory, thoracic and 7 6 mediastinal disorders Gastrointestinal Nausea and vomiting 12 11 disorders Abdominal pain 10 6 Sicca syndrome 3 2 GI haemorrhage 2 1 Hepato-biliary disorders Liver enzymes elevated 12 8 Skin and subcutaneous Rash (including exfoliative rash) 14 7 tissue disorders Pruritus 5 1 Dermatitis (including eczema) 3 1 Bruising (including purpura) 2 0 Musculoskeletal, Musculoskeletal pain 14 9 connective tissue and Muscle spasms (including blood creatine 5 4 bone disorders phosphokinase increased) Renal and urinary Haematuria 9 4 disorders Renal impairment 8 4 General disorders and Injection site reaction (including injection 20 13 administration site site erythema) conditions Oedema 5 4 Investigations Coagulation and bleeding disorders 9 4 (including activated partial thromboplastin time prolonged) Blood lactate dehydrogenase increased 2 1 Page 2 of 2 MedDRA a) Polyarticular Juvenile Idiopathic Arthritis
Nervous system disorders Headache 14 8 Vascular disorders Hypertension 6 3 Flushing 2 1 Page 1 of 2 Footnotes defined on next page of the table Table 33. Adverse Reactions Reported by Patients Treated With Adalimumab during Placebo-Controlled Period of Rheumatoid Arthritis Studies System Organ Classa) Adverse Reactiona) Adalimumab (n=1380) % Control (n=690) % Respiratory, thoracic and mediastinal disorders 7 6 Gastrointestinal disorders Nausea and vomiting 12 11 Abdominal pain 10 6 Sicca syndrome 3 2 GI haemorrhage 2 1 Hepato-biliary disorders Liver enzymes elevated 12 8 Skin and subcutaneous tissue disorders Rash (including exfoliative rash) 14 7 Pruritus 5 1 Dermatitis (including eczema) 3 1 Bruising (including purpura) 2 0 Musculoskeletal, connective tissue and bone disorders Musculoskeletal pain 14 9 Muscle spasms (including blood creatine phosphokinase increased) 5 4 Renal and urinary disorders Haematuria 9 4 Renal impairment 8 4 General disorders and administration site Injection site reaction (including injection site erythema) 20 13 conditions Oedema 5 4 Investigations Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged) 9 4 Blood lactate dehydrogenase increased 2 1 Page 2 of 2 a) MedDRA Polyarticular Juvenile Idiopathic Arthritis
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