| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mEC - (neo)adjuvant (NA) metastatic/advanced - esophageal cancer (mEC) mEC - (neo)adjuvant (NA) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| camrelizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: AE leading to death (grade 5); TRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Abdominal pain TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Hypersensitivity TRAE (grade 3-4); Hypertension TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Reactive cutaneous capillary endothelial proliferation TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Anaemia AE (grade 3-4) | statistically conclusive 29 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 31 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 66 % decrease in DOR but the degree if certainty is unassessable suggested 3.7-fold increase in objective responses (ORR) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Nausea 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 suggested 95 % decrease in Vomiting TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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