| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) squamous cell - mNSCLC - L1 squamous - mNSCLC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DOR; AE (any grade); 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); TRAE leading to death (grade 5); hepatitis (Autoimmune) AE (grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Colitis 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); Epistaxis AE (grade 3-4); Fatigue AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypophysitis AE (grade 3-4); Hypothyroidism AE (grade 3-4); Infusion-related reaction AE (grade 3-4); Myalgia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Pneumonitis AE (grade 3-4); Pyrexia AE (grade 3-4); Severe skin reactions AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Thyroiditis AE (grade 3-4); Vomiting AE (grade 3-4) | statistically conclusive 36 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 2.2-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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