| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mNSCLC - L1 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. Standard of Care (SoC) | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); STRAE (any grade); STRAE (grade 3-4); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia 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) ; Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Stomatitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Increase AST AE (grade 3-4) | suggested 80 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 79 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 80 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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