Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - all population

versus docetaxel
nivolumab alone vs. docetaxel 1

suggested 43 % decrease in TRAE leading to discontinuation (any grade)

inconclusive results for: DOR; STRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (grade 3-4); Acute kidney injury TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Eczema TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Erythema TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders TRAE (grade 3-4) ; Hypersensitivity TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus generalised TRAE (grade 3-4); Pruritus 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) ; Thyroiditis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4)

statistically conclusive 32 % decrease in deaths (OS) but the degree if certainty is unassessable

suggested 25 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable

suggested 21 % decrease in PFS (extension) but the degree if certainty is unassessable

statistically conclusive 23 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable

statistically conclusive 4.4-fold increase in objective responses (ORR) but the degree if certainty is unassessable

suggested 4.8-fold increase in objective responses (ORR) (extension) but the degree if certainty is unassessable

suggested 66 % decrease in STRAE (grade 3-4) but the degree if certainty is unassessable

suggested 65 % decrease in TRAE (any grade) but the degree if certainty is unassessable

suggested 85 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 98 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 97 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable

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