Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

MIBC - NA - all population muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - all population

versus placebo
nivolumab alone vs. placebo 1 noneinconclusive 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

statistically conclusive 30 % decrease in events or deaths (EFS) but the degree if certainty is unassessable

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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

statistically conclusive 45 % decrease in events or deaths (EFS) but the degree if certainty is unassessable

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