Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mGC or mGEJC - L2 - all population metastatic/advanced mGC or mGEJC mGC or mGEJC - 2nd Line (L2) mGC or mGEJC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus irinotecan | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
avelumab alone vs. irinotecan | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia 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); Nausea TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 66 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 78 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - |