Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sintillimab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DCR; DOR; AE (any grade); AE (grade 3-4); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); Diarrhoea TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Nausea AE (grade 3-4); Pyrexia AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 39 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 2.5-fold increase in objective responses (ORR) but the degree if certainty is unassessable suggested 69 % decrease in AE leading to death (grade 5) but the degree if certainty is unassessable | - |