Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
es-BC - TNBC - NA - PDL1 positive breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - Triple negative (TNBC) - 1st Line (L1) breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L1 - all population breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
atezolizumab plus nab-paclitaxel vs. Standard of Care (SoC) | 1 | inconclusive results for: deaths (OS); 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); hepatitis (Autoimmune) AE (grade 3-4); Abdominal pain AE (grade 3-4); Acute kidney injury AE (grade 3-4); Adrenal insufficiency AE (grade 3-4); Alopecia 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); Cardiomyopathy AE (grade 3-4); Chills AE (grade 3-4); Colitis 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); Dysgeusia AE (grade 3-4); Dysphonia AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Leucopenia AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Myalgia AE (grade 3-4); Myopathy AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Paraesthesia AE (grade 3-4); Pericarditis AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Pneumonia AE (grade 3-4); Pneumonitis AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Sepsis AE (grade 3-4); Stomatitis AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 20 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 22 % decrease in DOR but the degree if certainty is unassessable suggested 52 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
atezolizumab plus nab-paclitaxel vs. Standard of Care (SoC) | 1 | none | - | suggested 29 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 37 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 40 % decrease in DOR but the degree if certainty is unassessable suggested 96 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC-Triple negative (TNBC) - 2nd Line (L2) breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L2 - all population breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L2 - PDL1 positive breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - PDL1 positive |