MedDRA system Very common Common Uncommon organ class (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1000 to < 1/100) Gastrointestinal Vomiting disorders Abdominal pain Diarrhoea Constipation Nausea Hepatobiliary Increased liver Increased disorders enzymes (including bilirubin increased alanine aminotransferase, increased aspartate aminotransferase and gamma-glutamyl transferase) Skin and Rash subcutaneous tissue disorders Musculoskeletal and Back pain Arthralgia connective tissue Pain in extremity Bone pain disorders General disorders Pyrexia Chest pain and administration Peripheral oedema Oedema site conditions Fatigue Chills Investigations Increased weight Decreased immunoglobulins Injury, poisoning Infusion-related and procedural reactions and complications associated symptoms including wheezing, flushing, face swelling, dyspnoea, hypotension, and hypertension
MedDRA system organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1000 to < 1/100) Gastrointestinal disorders Vomiting Abdominal pain Diarrhoea Constipation Nausea Hepatobiliary disorders Increased liver enzymes (including increased alanine aminotransferase, increased aspartate aminotransferase and gamma-glutamyl transferase) Increased bilirubin Skin and subcutaneous tissue disorders Rash Musculoskeletal and connective tissue disorders Back pain Pain in extremity Arthralgia Bone pain General disorders and administration site conditions Pyrexia Peripheral oedema Fatigue Chills Chest pain Oedema Investigations Increased weight Decreased immunoglobulins Injury, poisoning and procedural complications Infusion-related reactions and associated symptoms including wheezing, flushing, face swelling, dyspnoea, hypotension, and hypertension
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