Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
durvalumab plus tremelimumab vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Alopecia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain 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); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Nausea AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 49 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 45 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Anaemia 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 suggested 88 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - |