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 alone vs. cetuximab plus platin plus 5FU 1 noneinconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR); AE leading to death (grade 5); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Skin and subcutaneous tissue disorders 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); Asthenia 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); Hypertension AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST 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); Vascular disorders AE (grade 3-4); Weight decreased AE (grade 3-4)

suggested 17 % decrease in deaths (OS) but the degree if certainty is unassessable

suggested 69 % decrease in AE (any grade) but the degree if certainty is unassessable

suggested 64 % decrease in AE leading to treatment discontinuation (any grade) but the degree if certainty is unassessable

suggested 95 % decrease in TRAE (any grade) but the degree if certainty is unassessable

suggested 91 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 96 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 98 % decrease in Blood and lymphatic system disorders TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 88 % decrease in Decreased appetite TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 75 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 93 % decrease in Gastrointestinal disorders TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 81 % decrease in General disorders and administration site conditions TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 74 % decrease in Metabolism and nutrition disorders TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 87 % decrease in Mucosal inflammation TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % 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 89 % decrease in Rash TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 71 % decrease in Severe skin reaction 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 96 % decrease in Thrombocytopenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 76 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable

suggested 90 % decrease in Blood and lymphatic system disorders AE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Febrile neutropenia AE (grade 3-4) but the degree if certainty is unassessable

suggested 67 % decrease in Gastrointestinal disorders AE (grade 3-4) but the degree if certainty is unassessable

suggested 58 % decrease in General disorders and administration site conditions AE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Leucopenia AE (grade 3-4) but the degree if certainty is unassessable

suggested 49 % decrease in Metabolism and nutrition disorders AE (grade 3-4) but the degree if certainty is unassessable

suggested 75 % decrease in Mucosal inflammation AE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Nausea AE (grade 3-4) but the degree if certainty is unassessable

suggested 60 % decrease in Nervous system disorders AE (grade 3-4) but the degree if certainty is unassessable

suggested 99 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable

suggested 89 % decrease in Rash AE (grade 3-4) but the degree if certainty is unassessable

suggested 95 % decrease in Stomatitis AE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Thrombocytopenia AE (grade 3-4) but the degree if certainty is unassessable

suggested 88 % decrease in Vomiting AE (grade 3-4) but the degree if certainty is unassessable

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