| 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 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 placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L1 - all population metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus ipilimumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. ipilimumab alone | 1 | none | inconclusive results for: DOR; TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Abdominal pain TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis 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); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | statistically conclusive 37 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 37 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 47 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 88 % decrease in Colitis TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L1 - BRAF mutant metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF mutant | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L1 - BRAF wild metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF wild | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus dacarbazine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. dacarbazine | 1 | none | inconclusive results for: DOR; AE (any grade); AE (grade 3-4); 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); Abdominal pain TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia 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); Dry skin 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); 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); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pancytopenia TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | statistically conclusive 58 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 54 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 58 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 3.5-fold increase in DOR (extension) but the degree if certainty is unassessable suggested 95 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); TRAE (any grade); TRAE leading to discontinuation (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Fatigue 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); Maculopapular rash TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Vitiligo TRAE (grade 3-4) | suggested 3.4-fold increase in objective responses (ORR) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 78 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L2 - BRAF mutant metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - BRAF mutant | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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