Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population

versus Standard of Care (SoC)
pembrolizumab alone vs. Standard of Care (SoC) 1 noneinconclusive 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

statistically conclusive 2.1-fold increase in objective responses (ORR) but the degree if certainty is unassessable

suggested 2.2-fold increase in objective responses (ORR) (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 52 % decrease in TRAE leading to discontinuation (any grade) 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 76 % decrease in Blood and lymphatic system disorders AE (grade 3-4) but the degree if certainty is unassessable

suggested 98 % decrease in Febrile neutropenia AE (grade 3-4) but the degree if certainty is unassessable

suggested 58 % decrease in Gastrointestinal disorders AE (grade 3-4) but the degree if certainty is unassessable

suggested 51 % decrease in General disorders and administration site conditions 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 73 % decrease in Nervous system disorders 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

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