Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mML - L1 - BRAF mutant metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF mutant | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus ipilimumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
nivolumab plus ipilimumab vs. ipilimumab alone | 1 | none | inconclusive results for: deaths (OS); PFS (extension); objective responses (ORR); objective responses (ORR) (extension) | suggested 62 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
atezolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: deaths (OS); DOR; objective responses (ORR); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Chorioretinopathy TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Erythema TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Hypothyroidism AE (grade 3-4) | suggested 22 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable | - |