| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mUC - L1 - all population metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus gemcitabine plus platin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. gemcitabine plus platin | 1 | none | inconclusive results for: deaths (OS); objective responses (ORR); AE leading to death (grade 5); SAE (any grade); TRAE leading to death (grade 5); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Asthenia AE (grade 3-4); Hypertension AE (grade 3-4) | suggested 79 % decrease in DOR but the degree if certainty is unassessable suggested 86 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 88 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 59 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 93 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 96 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 93 % 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 92 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 78 % decrease in Fatigue AE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Leucopenia AE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Nausea AE (grade 3-4) but the degree if certainty is unassessable suggested 100 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable suggested 90 % decrease in Vomiting AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. gemcitabine plus platin | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); objective responses (ORR); AE leading to treatment discontinuation (any grade); SAE (any grade); TRAE leading to death (grade 5); Abdominal pain TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Arthritis TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Gastritis TRAE (grade 3-4); Guillain-Barré syndrome TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hypersensitivity 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); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pancytopenia 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); Sepsis TRAE (grade 3-4); Stevens-Johnson syndrome TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 65 % decrease in DOR but the degree if certainty is unassessable suggested 63 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 50 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 87 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 90 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 89 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 94 % decrease in Nausea TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab plus tremelimumab vs. gemcitabine plus platin | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); objective responses (ORR); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Abdominal pain TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Arthritis TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Gastritis TRAE (grade 3-4); Guillain-Barré syndrome TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hypersensitivity 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); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pancytopenia 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); Sepsis TRAE (grade 3-4); Stevens-Johnson syndrome TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 56 % decrease in DOR but the degree if certainty is unassessable suggested 45 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 68 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 75 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 89 % decrease in Nausea TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. gemcitabine plus platin | 1 | none | inconclusive results for: deaths (OS); DOR; AE (grade 3-5); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); STRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Sarcoidosis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 22 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 48 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Hypertension AE (grade 3-4); Leucopenia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 17 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 96 % increase in CRR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue 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); Sarcoidosis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 62 % decrease in AE (grade 3-5) but the degree if certainty is unassessable suggested 61 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 92 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 92 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 88 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 100 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - L1 - PDL1 positive metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus gemcitabine plus platin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. gemcitabine plus platin | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); objective responses (ORR) | suggested 73 % decrease in DOR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab plus tremelimumab vs. gemcitabine plus platin | 1 | none | inconclusive results for: progression or deaths (PFS); objective responses (ORR) | suggested 26 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 62 % decrease in DOR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: progression or deaths (PFS); objective responses (ORR); AE (grade 3-4); AE leading to death (grade 5); SAE (any grade); TRAE leading to death (grade 5) | suggested 15 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 18 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 84 % decrease in DOR but the degree if certainty is unassessable suggested 62 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 44 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 72 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 67 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 60 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 58 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Constipation TRAE (grade 3-4) but the degree if certainty is unassessable suggested 63 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: PFS (extension); progression or deaths (PFS); DOR; DOR (extension); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Acute kidney injury AE (grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Back pain AE (grade 3-4); Blood creatinine increased AE (grade 3-4); Cardiac disorders 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); Dyspnoea AE (grade 3-4); Endocrine disorders AE (grade 3-4); Eye disorders AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Infections and infestations AE (grade 3-4); Injury, poisoning and procedure AE (grade 3-4); Metabolism and nutrition disorders AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Musculoskeletal and connective tissue disorders AE (grade 3-4); Myalgia AE (grade 3-4); Nausea AE (grade 3-4); Peripheral neuropathy 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); Renal and urinary disorders AE (grade 3-4); Respiratory, thoracic and mediastinal disorders AE (grade 3-4); Skin and subcutaneous tissue disorders AE (grade 3-4); Stomatitis AE (grade 3-4); Vascular disorders AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 27 % 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 72 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 39 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 83 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 81 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 93 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 75 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 86 % decrease in Asthenia AE (grade 3-4) but the degree if certainty is unassessable suggested 54 % decrease in Investigations AE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. Standard of Care (SoC) | 2 | none | inconclusive results for: deaths (OS); deaths (OS) (extension); progression or deaths (PFS); objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); SAE (any grade); STRAE (any grade); TRAE leading to death (grade 5); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Constipation TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4) | suggested 80 % decrease in DOR but the degree if certainty is unassessable suggested 62 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 45 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 80 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: progression or deaths (PFS); DOR | statistically conclusive 43 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 3.9-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - M - all population metastatic/advanced UC (mUC) - maintenance (M) mUC - M - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus BSC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| avelumab alone vs. BSC | 1 | none | inconclusive results for: AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); 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); Arthritis TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Guillain-Barré syndrome TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Infusion-related reactions 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); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); hepatitis (Autoimmune) AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain 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); Fatigue AE (grade 3-4); Hypothyroidism AE (grade 3-4); Infusion-related reaction 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) | statistically conclusive 31 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 24 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 46 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 38 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 85 % increase in DCR but the degree if certainty is unassessable suggested 7.5-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - M - PDL1 positive metastatic/advanced UC (mUC) - maintenance (M) mUC - M - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus BSC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| avelumab alone vs. BSC | 1 | none | - | statistically conclusive 44 % 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 suggested 54 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 44 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 2.0-fold increase in DCR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
MIBC - NA - all population muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus no additional treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. no additional treatment | 1 | none | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. placebo | 1 | none | inconclusive results for: TRAE (any grade); TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Dermatitis acneiform TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Eczema TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Erythema TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastrointestinal disorders 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); Nephritis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash 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) ; Thyroiditis TRAE (grade 3-4); Urticaria TRAE (grade 3-4); Skin and subcutaneous tissue disorders AE (grade 3-4) | suggested 28 % decrease in RFS/DFS but the degree if certainty is unassessable suggested 25 % decrease in DMFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
MIBC - NA - PDL1 positive muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. placebo | 1 | none | - | suggested 45 % decrease in RFS/DFS but the degree if certainty is unassessable suggested 39 % decrease in DMFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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