| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mEC - (neo)adjuvant (NA) metastatic/advanced - esophageal cancer (mEC) mEC - (neo)adjuvant (NA) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. placebo | 1 | none | inconclusive results for: AE (any grade); AE (grade 3-4); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); SAE (any grade); SAE (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4) | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mEC - 1st line (L1) metastatic/advanced - esophageal cancer (mEC) mEC - 1st line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mEC - 2nd line (L2) metastatic/advanced - esophageal cancer (mEC) mEC - 2nd line (L2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE leading to death (grade 5); STRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Alopecia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Rash TRAE (grade 3-4); Stomatitis TRAE (grade 3-4) | statistically conclusive 23 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 54 % decrease in STRAE (grade 3-4) but the degree if certainty is unassessable suggested 90 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 87 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 81 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 89 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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