| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus cetuximab plus platin plus 5FU | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus 5FU plus platin vs. cetuximab plus platin plus 5FU | 1 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood and lymphatic system disorders TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Fatigue TRAE (grade 3-4); General disorders and administration site conditions 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); Leucopenia TRAE (grade 3-4); Metabolism and nutrition disorders TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Acute kidney injury AE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Blood and lymphatic system disorders AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Gastrointestinal disorders AE (grade 3-4); General disorders and administration site conditions AE (grade 3-4); Hypertension AE (grade 3-4); Increase AST AE (grade 3-4); Leucopenia AE (grade 3-4); Metabolism and nutrition disorders AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Nausea AE (grade 3-4); Nervous system disorders AE (grade 3-4); Neutropenia AE (grade 3-4); Pneumonitis AE (grade 3-4); Renal and urinary disorders AE (grade 3-4); Respiratory, thoracic and mediastinal disorders AE (grade 3-4); Sepsis AE (grade 3-4); Skin and subcutaneous tissue disorders AE (grade 3-4); Stomatitis AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vascular disorders AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 23 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 28 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 94 % decrease in Rash TRAE (grade 3-4) but the degree if certainty is unassessable suggested 94 % decrease in Rash AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus cetuximab plus platin plus 5FU | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus 5FU plus platin vs. cetuximab plus platin plus 5FU | 2 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR) | statistically conclusive 37 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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