Table 32 contains adverse reactions (ADRs), which in some cases represent groups of related Preferred Terms to represent a medical concept. The ADRs presented in the table were included based on criteria including statistical significance, doubling in rate in adalimumab treated patients compared to placebo treated patients, a rate greater than 1% for adalimumab treated patients and medical importance assessment. Rheumatoid Arthritis Table 33 contains adverse reactions reported in at least 1% of RA patients with higher incidence (≥ 1%) in patients treated with adalimumab compared to control in 4 RA trials (RA study I-IV). In general, the adverse reactions across all indications were similar to those seen in RA patients. 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) % % Infections and Respiratory tract infections (including 39 33 infestations lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral) Oral infections (including herpes simplex, 7 5 oral herpes and tooth infections) Reproductive tract infections (including 3 1 vulvovaginal mycotic infection) Blood and the lymphatic Anaemia 13 8 system disorders Leucopaenia (including neutropaenia and 14 8 agranulocytosis) Leucocystosis 1 0 Thrombocytopenia 1 0 Metabolism and nutrition Lipids increased 17 8 disorders Uric acid increased 6 3 sodium abnormal 10 3 Hypokalaemia 3 2 Hypophosphotaemia 2 1 Blood potassium increased 3 1
Table 32 contains adverse reactions (ADRs), which in some cases represent groups of related Preferred Terms to represent a medical concept. The ADRs presented in the table were included based on criteria including statistical significance, doubling in rate in adalimumab treated patients compared to placebo treated patients, a rate greater than 1% for adalimumab treated patients and medical importance assessment. Rheumatoid Arthritis Table 33 contains adverse reactions reported in at least 1% of RA patients with higher incidence (≥ 1%) in patients treated with adalimumab compared to control in 4 RA trials (RA study I-IV). In general, the adverse reactions across all indications were similar to those seen in RA patients. 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) % Infections and infestations Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral) 39 33 Oral infections (including herpes simplex, oral herpes and tooth infections) 7 5 Reproductive tract infections (including vulvovaginal mycotic infection) 3 1 Blood and the lymphatic system disorders Anaemia 13 8 Leucopaenia (including neutropaenia and agranulocytosis) 14 8 Leucocystosis 1 0 Thrombocytopenia 1 0 Metabolism and nutrition disorders Lipids increased 17 8 Uric acid increased 6 3 sodium abnormal 10 3 Hypokalaemia 3 2 Hypophosphotaemia 2 1 Blood potassium increased 3 1