| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA) metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. placebo | 1 | none | - | suggested 46 % decrease in deaths (OS) but the degree if certainty is unassessable statistically conclusive 32 % decrease in RFS/DFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
metastatic/advanced RCC (mRCC) - 1st line (L1) metastatic/advanced RCC (mRCC) - 1st line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus sunitinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. sunitinib | 1 | none | inconclusive results for: progression or deaths (PFS); objective responses (ORR); AE (any grade); AE leading to death (grade 5); TRAE leading to death (grade 5); Colitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4) | suggested 70 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 79 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 85 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus bevacizumab vs. sunitinib | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Adrenal insufficiency TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dysphonia TRAE (grade 3-4); Epistaxis TRAE (grade 3-4); Headache TRAE (grade 3-4); Hypertension TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Proteinuria TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 95 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 65 % decrease in Diarrhoea TRAE (grade 3-4) but the degree if certainty is unassessable suggested 71 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 89 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 81 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| avelumab plus axitinib vs. sunitinib | 1 | none | inconclusive results for: deaths (OS); DOR; AE (grade 3-4); AE leading to death (grade 5); TRAE (any grade); TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Chills TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dysphonia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hypertension 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); Nausea TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased 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); Chills 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); Dizziness AE (grade 3-4); Dry skin AE (grade 3-4); Dysgeusia AE (grade 3-4); Dyspepsia AE (grade 3-4); Dysphonia AE (grade 3-4); Dyspnoea AE (grade 3-4); Epistaxis AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Hypertension 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); Oropharyngeal pain AE (grade 3-4); Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4); Peripheral oedema 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) | suggested 31 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 2.9-fold increase in objective responses (ORR) but the degree if certainty is unassessable suggested 96 % decrease in Anaemia 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 82 % decrease in Anaemia 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 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus cabozantinib vs. sunitinib | 1 | none | inconclusive results for: DOR; DOR (extension); TRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade) | statistically conclusive 40 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 30 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 44 % decrease in PFS (extension) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. sunitinib | 3 | none | inconclusive results for: progression or deaths (PFS); DOR; TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blister TRAE (grade 3-4); Blood creatinine increased 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); Eczema TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Erythema TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders 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); Increased lipase level TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus generalised TRAE (grade 3-4); Pruritus 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) ; Skin exfoliation TRAE (grade 3-4); Skin hypopigmentation TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Urticaria TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 32 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 29 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 15 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 35 % increase in objective responses (ORR) but the degree if certainty is unassessable suggested 59 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 51 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 56 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Hypertension TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus sunitinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus bevacizumab vs. sunitinib | 1 | none | inconclusive results for: progression or deaths (PFS); objective responses (ORR) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mRCC - L1 - PDL1 positive metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus sunitinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. sunitinib | 1 | none | inconclusive results for: progression or deaths (PFS); objective responses (ORR) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus bevacizumab vs. sunitinib | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| avelumab plus axitinib vs. sunitinib | 1 | none | inconclusive results for: DOR | suggested 31 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 38 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 3.4-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
metastatic/advanced RCC (mRCC) - 2nd line (L2) metastatic/advanced RCC (mRCC) - 2nd line (L2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus everolimus | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. everolimus | 1 | none | inconclusive results for: deaths (OS) (extension); progression or deaths (PFS); DOR; DOR (extension); objective responses (ORR) (extension); TRAE leading to death (grade 5); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Epistaxis TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4) | statistically conclusive 27 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 50 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 60 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 79 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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