Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:
very common (≥ 1/10); common (≥ 1/100 to rare ( 12 System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to Uncommon ≥ 1/1,000 to Rare ≥ 1/10,000 to Very Rare Not Known (Cannot be Estimated from Available Data) Infections and infestations Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)* Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)* Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)* Hepatitis B reactivation, listeria Neoplasms benign, malignant and unspecified (including cysts and polyps) Non-melanoma skin cancers* (see section 4.4) Malignant melanoma (see section 4.4), lymphoma, leukaemia Merkel cell carcinoma (see section 4.4), Kaposi Sarcoma Blood and lymphatic system disorders Thrombocytopenia, anaemia, leukopenia, neutropenia Pancytopenia* Aplastic anaemia* Histiocytosis haematophagic (macrophage activation syndrome)* Immune system disorders Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation* Vasculitis (including anti- neutrophilic cytoplasmic antibody positive vasculitis) Serious allergic/ anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis Worsening of symptoms of dermatomyositis Nervous system disorders Headache CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy,