Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
atezolizumab alone vs. Standard of Care (SoC) | 2 | none | inconclusive results for: deaths (OS); deaths (OS) (extension); progression or deaths (PFS); 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); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Constipation TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4) | suggested 80 % decrease in DOR but the degree if certainty is unassessable suggested 62 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 45 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 80 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - |