Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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squamous - mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) squamous cell - mNSCLC - L2 squamous - mNSCLC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus docetaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
nivolumab alone vs. docetaxel | 1 | none | inconclusive results for: DOR; DOR (extension); objective responses (ORR) (extension); TRAE leading to death (grade 5); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | statistically conclusive 41 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 69 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 52 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 90 % decrease in SAE (grade 3-4) but the degree if certainty is unassessable suggested 77 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 78 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 94 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 91 % 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 | - |