Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mGC or mGEJC - L1 - HER2 neg/PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - HER2 neg/PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - L1 - HER2 negative metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - HER2 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - L2 - all population metastatic/advanced mGC or mGEJC mGC or mGEJC - 2nd Line (L2) mGC or mGEJC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pembrolizumab alone vs. paclitaxel | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4) | suggested 79 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - L2 - PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 2nd Line (L2) mGC or mGEJC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pembrolizumab alone vs. paclitaxel | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - M - HER2 negative metastatic/advanced mGC or mGEJC mGC or mGEJC - maintenance (M) mGC or mGEJC - M - HER2 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - M - HER2 neg/PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - maintenance (M) mGC or mGEJC - M - HER2 neg/PDL1 positive |