Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mGC or mGEJC - M - HER2 negative metastatic/advanced mGC or mGEJC mGC or mGEJC - maintenance (M) mGC or mGEJC - M - HER2 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
avelumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); SAE (any grade); STRAE (any grade); TRAE leading to death (grade 5) | suggested 53 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable | - |