Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

mML - NA - all population metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - all population

versus interferon alpha
Ipilimumab (10 mg/kg) vs. interferon alpha 1 noneinconclusive results for: deaths (OS); RFS/DFS; AE (any grade); AE leading to death (grade 5)

suggested 44 % decrease in AE (grade 3-4) but the degree if certainty is unassessable

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ipilimumab alone vs. interferon alpha 1 noneinconclusive results for: RFS/DFS; AE (any grade); AE leading to death (grade 5)

statistically conclusive 17 % decrease in deaths (OS) but with a low degree of certainty due to high risk of bias

suggested 58 % decrease in AE (grade 3-4) but with a low degree of certainty due to high risk of bias

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versus placebo
Ipilimumab (10 mg/kg) vs. placebo 1 noneinconclusive results for: AE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders TRAE (grade 3-4) ; Hypophysitis TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Colitis AE (grade 3-4); Hypophysitis AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4)

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

suggested 27 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable

statistically conclusive 24 % decrease in MFS but the degree if certainty is unassessable

suggested 24 % decrease in MFS (extension) but the degree if certainty is unassessable

suggested 25 % decrease in RFS (extension) but the degree if certainty is unassessable

statistically conclusive 25 % decrease in RFS/DFS but the degree if certainty is unassessable

suggested 89 % decrease in AE (grade 3-4) but the degree if certainty is unassessable

suggested 96 % decrease in Abdominal pain AE (grade 3-4) but the degree if certainty is unassessable

suggested 99 % decrease in Cough AE (grade 3-4) but the degree if certainty is unassessable

suggested 94 % decrease in Decreased appetite AE (grade 3-4) but the degree if certainty is unassessable

suggested 74 % decrease in Diarrhoea AE (grade 3-4) but the degree if certainty is unassessable

suggested 95 % decrease in Fatigue AE (grade 3-4) but the degree if certainty is unassessable

suggested 96 % decrease in Headache AE (grade 3-4) but the degree if certainty is unassessable

suggested 99 % decrease in Nausea AE (grade 3-4) but the degree if certainty is unassessable

suggested 86 % decrease in Pruritus AE (grade 3-4) but the degree if certainty is unassessable

suggested 79 % decrease in Pyrexia AE (grade 3-4) but the degree if certainty is unassessable

suggested 94 % decrease in Rash AE (grade 3-4) but the degree if certainty is unassessable

suggested 93 % decrease in Vomiting AE (grade 3-4) but the degree if certainty is unassessable

suggested 98 % decrease in Weight decreased AE (grade 3-4) but the degree if certainty is unassessable

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