| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus gp100 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ipilimumab alone vs. gp100 | 1 | none | inconclusive results for: progression or deaths (PFS); DOR; AE (any grade); AE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Gastrointestinal disorders TRAE (grade 3-4) ; Hepatitis TRAE (grade 3-4); Hepatobiliary disorders 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); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Vitiligo TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Anaemia 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); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Nausea AE (grade 3-4); Pyrexia AE (grade 3-4); Vomiting AE (grade 3-4) | statistically conclusive 34 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 8.2-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ipilimumab plus gp100 vs. gp100 | 1 | none | inconclusive results for: progression or deaths (PFS); objective responses (ORR); 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); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Gastrointestinal disorders TRAE (grade 3-4) ; Hepatitis TRAE (grade 3-4); Hepatobiliary disorders 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); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Vitiligo TRAE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Nausea AE (grade 3-4); Pyrexia AE (grade 3-4); Vomiting AE (grade 3-4) | statistically conclusive 32 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 32 % decrease in DOR but the degree if certainty is unassessable suggested 71 % decrease in Abdominal pain AE (grade 3-4) but the degree if certainty is unassessable suggested 67 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus ipilimumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ipilimumab (10 mg/kg) vs. ipilimumab alone | 1 | none | inconclusive results for: progression or deaths (PFS); DCR; DOR; objective responses (ORR); 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); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Eye disorders TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Guillain-Barré syndrome TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hypersensitivity 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); Maculopapular rash TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pancytopenia TRAE (grade 3-4); Pericarditis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Polymyalgia Rheumatica TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4) | statistically conclusive 16 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ipilimumab plus gp100 vs. ipilimumab alone | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Gastrointestinal disorders TRAE (grade 3-4) ; Hepatitis TRAE (grade 3-4); Hepatobiliary disorders 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); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Vitiligo TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Anaemia 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); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Nausea AE (grade 3-4); Pyrexia AE (grade 3-4); Vomiting AE (grade 3-4) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ipilimumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DCR; DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); TRAE (any grade); TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Hepatitis 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); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Asthenia 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); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Nausea AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 28 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 31 % decrease in deaths (OS) (extension) 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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