Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population

versus placebo plus SoC
ipilimumab plus SoC vs. placebo plus SoC 1 noneinconclusive results for: DCR; DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); TRAE (any grade); TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Asthenia AE (grade 3-4); Chills AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Nausea AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4)

statistically conclusive 28 % decrease in deaths (OS) but the degree if certainty is unassessable

suggested 31 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable

statistically conclusive 24 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable

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