Table 2

Adverse events by grade and dose level

Dose level, mg/kgToxicity grade
1234
0.1 Pharyngitis, eyelid blisters, tachycardia, dizziness, headache Leucocytosis, diarrhea, shoulder pain, bronchitis (2), vaginosis Arthritis*, pneumonitis  
0.33 Palpitations, chest pain, diarrhea (2), nausea, cough Blurring of vision, abdominal pain/constipation, hypercalcemia, hyperglycemia, knee swelling Anemia, thrombocytopenia, pneumonia, neutropenia/fever Infection, hip fracture 
0.66 Hypothyroidism, elevated AST, hyperglycemia, acute GVHD (skin) Hyperthyroidism*, cellulitis, bone pain, cough, pneumonia (2) Anemia  
1.0 Anemia, thrombocytopenia, elevated ALT/AST, elevated alkaline phosphatase Hypotension, urinary retention Elevated AST/ALT Neutropenia (transient)* 
3.0 Chills, fatigue (2), fever (2)*, night sweats, anemia, thrombocytopenia, petichiae, skin dryness, rash, hypercalcemia, hypocalcemia, hypokalemia, hypernatremia, hyponatremia, muscle cramps*, dizziness (2)*, headache, insomnia, photophobia, colitis*, diarrhea*, elevated alk. phos., elevated AST/ALT*, nausea (2), vomiting*, increased creatinine, vaginosis, pharyngitis*, agitation Fatigue (2), Fever (2 + 1)*, sweats*, insomnia, pruritis*, rash/desquamation*, abdominal pain, backache*, arthritis*, headache, sensory neuropathy, cough, dyspnea, pneumonia, anxiety Leucocytosis, fever, neutropenic fever, dyspnea, mucositis Pneumonitis* 
Dose level, mg/kgToxicity grade
1234
0.1 Pharyngitis, eyelid blisters, tachycardia, dizziness, headache Leucocytosis, diarrhea, shoulder pain, bronchitis (2), vaginosis Arthritis*, pneumonitis  
0.33 Palpitations, chest pain, diarrhea (2), nausea, cough Blurring of vision, abdominal pain/constipation, hypercalcemia, hyperglycemia, knee swelling Anemia, thrombocytopenia, pneumonia, neutropenia/fever Infection, hip fracture 
0.66 Hypothyroidism, elevated AST, hyperglycemia, acute GVHD (skin) Hyperthyroidism*, cellulitis, bone pain, cough, pneumonia (2) Anemia  
1.0 Anemia, thrombocytopenia, elevated ALT/AST, elevated alkaline phosphatase Hypotension, urinary retention Elevated AST/ALT Neutropenia (transient)* 
3.0 Chills, fatigue (2), fever (2)*, night sweats, anemia, thrombocytopenia, petichiae, skin dryness, rash, hypercalcemia, hypocalcemia, hypokalemia, hypernatremia, hyponatremia, muscle cramps*, dizziness (2)*, headache, insomnia, photophobia, colitis*, diarrhea*, elevated alk. phos., elevated AST/ALT*, nausea (2), vomiting*, increased creatinine, vaginosis, pharyngitis*, agitation Fatigue (2), Fever (2 + 1)*, sweats*, insomnia, pruritis*, rash/desquamation*, abdominal pain, backache*, arthritis*, headache, sensory neuropathy, cough, dyspnea, pneumonia, anxiety Leucocytosis, fever, neutropenic fever, dyspnea, mucositis Pneumonitis* 
*

Events that the investigator felt were at least possibly related to ipilimumab.

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