Adverse events by grade and dose level
Dose level, mg/kg . | Toxicity grade . | |||
---|---|---|---|---|
1 . | 2 . | 3 . | 4 . | |
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/kg . | Toxicity grade . | |||
---|---|---|---|---|
1 . | 2 . | 3 . | 4 . | |
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.