| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus paclitaxel vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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