(≥ 10%) (≥1% to <10%) (≥ 10%) (≥1% to <10%) Acute infusion hypertension, rash, hypertension, nausea, reactions* pruritus, chills, rash, pyrexia, pyrexia, rhinitis, pruritus, urticaria, throat irritation throat irritation, hot flush, hypotension Gastrointestinal dyspepsia dyspepsia disorders Infections and any infection urinary tract any infection, infestations infections upper respiratory tract infection Metabolism and hypercholesterolemia nutritional disorders Musculoskeletal arthralgia/ arthralgia/ disorders musculoskeletal pain musculoskeletal pain, osteoarthritis Nervous System migraine paraesthesia disorders † This table include all events with an incidence difference of ≥ 2 % for rituximab compared to placebo. * Reactions occurring during or within 24 hours of infusion. The following adverse events were reported at a frequency between 1% and 2% greater in the rituximab-arms compared to control arms: respiratory tract infections/pneumonia, abdominal pain upper, muscle spasms, asthenia. In addition to the events tabulated above, medically significant events reported rarely in the rituximab-treated population and considered potential reactions to treatment include the following: General disorders: generalised oedema Respiratory Disorders: bronchospasm, wheezing, laryngeal oedema Skin and Subcutaneous Disorders: angioneurotic oedema, generalised pruritis Immune system Disorders: anaphylaxis, anaphylactoid reaction Multiple Courses Multiple courses of treatment are associated with a similar ADR profile to that observed following first exposure. However, worsening of infusion or allergic reactions and failure to B cell deplete following rituximab cannot be excluded in HACA positive patients after repeated exposure to rituximab on the basis of the available data. The incidence of acute infusion reactions following subsequent treatment courses was generally lower than the incidence following the first infusion of rituximab.
(≥ 10%) (≥1% to <10%) (≥ 10%) (≥1% to <10%) Acute infusion reactions* hypertension, rash, pruritus, chills, pyrexia, rhinitis, throat irritation hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension Gastrointestinal disorders dyspepsia dyspepsia Infections and infestations any infection urinary tract infections any infection, upper respiratory tract infection Metabolism and nutritional disorders hypercholesterolemia Musculoskeletal disorders arthralgia/ musculoskeletal pain arthralgia/ musculoskeletal pain, osteoarthritis Nervous System disorders migraine paraesthesia † This table include all events with an incidence difference of ≥ 2 % for rituximab compared to placebo. * Reactions occurring during or within 24 hours of infusion. The following adverse events were reported at a frequency between 1% and 2% greater in the rituximab-arms compared to control arms: respiratory tract infections/pneumonia, abdominal pain upper, muscle spasms, asthenia. In addition to the events tabulated above, medically significant events reported rarely in the rituximab-treated population and considered potential reactions to treatment include the following: General disorders: generalised oedema Respiratory Disorders: bronchospasm, wheezing, laryngeal oedema Skin and Subcutaneous Disorders: angioneurotic oedema, generalised pruritis Immune system Disorders: anaphylaxis, anaphylactoid reaction Multiple Courses Multiple courses of treatment are associated with a similar ADR profile to that observed following first exposure. However, worsening of infusion or allergic reactions and failure to B cell deplete following rituximab cannot be excluded in HACA positive patients after repeated exposure to rituximab on the basis of the available data. The incidence of acute infusion reactions following subsequent treatment courses was generally lower than the incidence following the first infusion of rituximab.