Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus ipilimumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Ipilimumab (10 mg/kg) vs. ipilimumab alone | 1 | none | inconclusive results for: progression or deaths (PFS); DCR; DOR; objective responses (ORR); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Eye disorders TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Guillain-Barré syndrome TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hypersensitivity TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pancytopenia TRAE (grade 3-4); Pericarditis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Polymyalgia Rheumatica TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4) | statistically conclusive 16 % decrease in deaths (OS) but the degree if certainty is unassessable | - |