| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
metastatic/advanced OC (mOC) - 2nd line (L2) metastatic/advanced OC (mOC) - 2nd line (L2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus nivolumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. nivolumab alone | 1 | none | inconclusive results for: deaths (OS); objective responses (ORR); AE (grade 3-4); AE leading to death (grade 5); TRAE (grade 3-4); TRAE leading to death (grade 5); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthritis TRAE (grade 3-4); Colitis TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4) | suggested 47 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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