| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
multiple myeloma - 1st line (L1) multiple myeloma - 1st line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus lenalidomide and dexamethasone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus lenalidomide and dexamethasone vs. lenalidomide and dexamethasone | 1 | none | inconclusive results for: deaths (OS); DCR; DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hypersensitivity TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Rash TRAE (grade 3-4); Stevens-Johnson syndrome TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Anaemia 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); Neutropenia AE (grade 3-4); Peripheral oedema AE (grade 3-4); Pneumonia AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4) | - | 22 % increase in progression or deaths (PFS) with safety concern |
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