Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mGC or mGEJC - L1 - PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pembrolizumab alone vs. placebo plus SoC | 1 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR) | suggested 31 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pembrolizumab plus SoC vs. placebo plus SoC | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); TRAE (any grade); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 60 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE (any grade); AE leading to death (grade 5); Alopecia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 91 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 89 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 90 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 91 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 80 % decrease in Diarrhoea TRAE (grade 3-4) but the degree if certainty is unassessable suggested 94 % decrease in Fatigue 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 Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Vomiting TRAE (grade 3-4) but the degree if certainty is unassessable | - |