metaEvidence - overview

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			Statistically conclusive or suggested result	Inconclusive results	Uncertain results	Safety results
mHNSCC - L2 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - all population
versus Standard of Care (SoC)
	pembrolizumab alone vs. Standard of Care (SoC)	1	none	inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Cardiac disorders TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Epistaxis TRAE (grade 3-4); Eye disorders TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastritis TRAE (grade 3-4); General disorders and administration site conditions TRAE (grade 3-4); Guillain-Barré syndrome TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hepatobiliary disorders TRAE (grade 3-4) ; Hypersensitivity TRAE (grade 3-4); Hypertension 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); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Metabolism and nutrition disorders TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Musculoskeletal and connective tissue disorders TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancytopenia TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus generalised TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Renal and urinary disorders TRAE (grade 3-4) ; Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sepsis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Skin exfoliation TRAE (grade 3-4); Stevens-Johnson syndrome TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vascular disorders TRAE (grade 3-4); Weight decreased TRAE (grade 3-4); Back pain AE (grade 3-4); Dizziness AE (grade 3-4)	statistically conclusive 20 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 67 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 76 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 90 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Blood and lymphatic system disorders TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Febrile neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 65 % decrease in Gastrointestinal disorders TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable	-
mHNSCC - L2 - PDL1 negative metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 negative
mHNSCC - L2 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 positive
versus Standard of Care (SoC)
	pembrolizumab alone vs. Standard of Care (SoC)	1	none	inconclusive results for: progression or deaths (PFS); DOR	statistically conclusive 26 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 90 % increase in objective responses (ORR) but the degree if certainty is unassessable	-