| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
laHNSCC - 1st line (L1) locally advanced (laHNSCC) laHNSCC - 1st line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L2 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Dermatitis acneiform TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4) | suggested 55 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 71 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 65 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L2 - PDL1 negative metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L2 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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