Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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metastatic/advanced RCC (mRCC) - 1st line (L1) metastatic/advanced RCC (mRCC) - 1st line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus sunitinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pembrolizumab plus axitinib vs. sunitinib | 1 | none | inconclusive results for: DOR; AE leading to death (grade 5); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Adrenal insufficiency TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia 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); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dysphonia TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hypertension TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis 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); 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); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Proteinuria TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Blood creatinine increased AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dysgeusia AE (grade 3-4); Dyspepsia AE (grade 3-4); Dysphonia AE (grade 3-4); Dyspnoea AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Nausea AE (grade 3-4); Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4); Proteinuria AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Stomatitis AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 47 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 32 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 29 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 93 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 54 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 86 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 59 % decrease in Fatigue AE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
pembrolizumab plus lenvatinib vs. sunitinib | 1 | none | inconclusive results for: DOR; AE (any grade); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); Arthralgia AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dysgeusia AE (grade 3-4); Dysphonia AE (grade 3-4); Fatigue AE (grade 3-4); Hypertension AE (grade 3-4); Hypothyroidism AE (grade 3-4); Nausea AE (grade 3-4); Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4); Proteinuria AE (grade 3-4); Rash AE (grade 3-4); Stomatitis AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 34 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 89 % decrease in AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mRCC - L1 - PDL1 negative metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mRCC - L1 - PDL1 positive metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 positive |