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Safety and tolerability profile of BAVENCIO® (avelumab) in mMCC

  BAVENCIO (N=88)
Adverse Reactions (≥ 10%) All Grades (%)  Grade 3-4 (%)
General Disorders 
Fatiguea 50 
Infusion-related reactionb 22 
Peripheral edemac 20 
Musculoskeletal and Connective Tissue Disorders 
Musculoskeletal paind 32 
Arthralgia 16  1
Gastrointestinal Disorders 
Diarrhea 23 
Nausea 22 
Constipation 17 
Abdominal paine 16 
Vomiting 13 
Skin and Subcutaneous Tissue Disorders
Rashf 22 
Pruritusg 10 
Metabolism and Nutrition Disorders 
Decreased appetite  20 
Decreased weight  15 
Respiratory, Thoracic, and Mediastinal Disorders
Cough 18 
Dyspneah 11 
Nervous System Disorders
Dizziness  14 
Headache  10 
Vascular Disorders
Hypertension  13 

aFatigue is a composite term that includes fatigue and asthenia. bInfusion-related reaction is a composite term that includes drug hypersensitivity, hypersensitivity, chills, pyrexia, back pain, and hypotension. cPeripheral edema is a composite term that includes peripheral edema and peripheral swelling. dMusculoskeletal pain is a composite term that includes back pain, myalgia, neck pain, and pain in extremity. eAbdominal pain is a composite term that includes abdominal pain and abdominal pain upper. fRash is a composite term that includes rash maculopapular, erythema, and dermatitis bullous. gPruritus is a composite term that includes pruritis and pruritis generalized. hDyspnea is a composite term that includes dyspnea and dyspnea exertional.