| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mML - NA - all population metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus interferon alpha | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ipilimumab (10 mg/kg) vs. interferon alpha | 1 | none | inconclusive results for: deaths (OS); RFS/DFS; AE (any grade); AE leading to death (grade 5) | suggested 44 % decrease in AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ipilimumab alone vs. interferon alpha | 1 | none | inconclusive results for: RFS/DFS; AE (any grade); AE leading to death (grade 5) | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Ipilimumab (10 mg/kg) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. Ipilimumab (10 mg/kg) | 1 | none | inconclusive results for: deaths (OS); AE (any grade); TRAE leading to death (grade 5); Abdominal pain TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Headache TRAE (grade 3-4); Hypersensitivity TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Renal and urinary disorders TRAE (grade 3-4) ; Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | suggested 27 % decrease in MFS but the degree if certainty is unassessable suggested 29 % decrease in RFS (extension) but the degree if certainty is unassessable statistically conclusive 35 % decrease in RFS/DFS but the degree if certainty is unassessable suggested 72 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 75 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 80 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 85 % decrease in Diarrhoea TRAE (grade 3-4) but the degree if certainty is unassessable suggested 82 % decrease in Hypophysitis TRAE (grade 3-4) but the degree if certainty is unassessable suggested 90 % decrease in Increase AST TRAE (grade 3-4) but the degree if certainty is unassessable suggested 65 % decrease in Rash TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus nivolumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. nivolumab alone | 1 | none | inconclusive results for: AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); SAE (any grade); SAE (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Blood and lymphatic system disorders TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Ear and labyrinth disorders TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Eye disorders TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastritis TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; General disorders and administration site conditions TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hepatobiliary disorders 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); Increased lipase level 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); Musculoskeletal and connective tissue disorders TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sarcoidosis TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 60 % decrease in RFS/DFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ipilimumab (10 mg/kg) vs. placebo | 1 | none | inconclusive results for: AE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders TRAE (grade 3-4) ; Hypophysitis TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Colitis AE (grade 3-4); Hypophysitis AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4) | statistically conclusive 28 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 27 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable statistically conclusive 24 % decrease in MFS but the degree if certainty is unassessable suggested 24 % decrease in MFS (extension) but the degree if certainty is unassessable suggested 25 % decrease in RFS (extension) but the degree if certainty is unassessable statistically conclusive 25 % decrease in RFS/DFS but the degree if certainty is unassessable suggested 89 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Abdominal pain AE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Cough AE (grade 3-4) but the degree if certainty is unassessable suggested 74 % decrease in Diarrhoea AE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Fatigue AE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Headache AE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Nausea AE (grade 3-4) but the degree if certainty is unassessable suggested 86 % decrease in Pruritus AE (grade 3-4) but the degree if certainty is unassessable suggested 79 % decrease in Pyrexia AE (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 suggested 93 % decrease in Vomiting AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. placebo | 1 | none | inconclusive results for: AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); SAE (any grade); SAE (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Blood and lymphatic system disorders TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Eye disorders TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastritis TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; General disorders and administration site conditions TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hepatobiliary disorders 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); Increased lipase level 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); Musculoskeletal and connective tissue disorders TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sarcoidosis TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | statistically conclusive 44 % decrease in RFS/DFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. placebo | 1 | none | inconclusive results for: AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); SAE (any grade); SAE (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Blood and lymphatic system disorders TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Ear and labyrinth disorders TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Eye disorders TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastritis TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; General disorders and administration site conditions TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hepatobiliary disorders 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); Increased lipase level 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); Musculoskeletal and connective tissue disorders TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sarcoidosis TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | statistically conclusive 77 % decrease in RFS/DFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. placebo | 1 | inconclusive results for: AE (any grade); AE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Gastrointestinal disorders TRAE (grade 3-4) ; Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sarcoidosis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4) | suggested 47 % decrease in MFS but the degree if certainty is unassessable statistically conclusive 43 % decrease in RFS/DFS but the degree if certainty is unassessable statistically conclusive 40 % decrease in DMFS but the degree if certainty is unassessable | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. placebo | 1 | none | - | suggested 43 % decrease in RFS (extension) but the degree if certainty is unassessable statistically conclusive 46 % decrease in RFS/DFS but the degree if certainty is unassessable statistically conclusive 40 % decrease in DMFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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