| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - L1 - PDL1 positive metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
MIBC - NA - PDL1 positive muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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