Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

metastatic (mCRPC) - 1st line (L1) castration-resistant prostate cancer (CRPC) metastatic (mCRPC) - 1st line (L1)

versus placebo
ipilimumab alone vs. placebo 2

suggested 31 % decrease in progression or deaths (PFS)

inconclusive results for: deaths (OS); AE (any grade); AE (grade 3-4); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); SAE (any grade); SAE (grade 3-4); STRAE (grade 3-4); TRAE (any grade); TRAE (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); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Fatigue TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatitis TRAE (grade 3-4); Hepatobiliary disorders TRAE (grade 3-4) ; Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neurologic TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Vomiting TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Acute kidney injury AE (grade 3-4); Adrenal insufficiency AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Blood and lymphatic system disorders AE (grade 3-4); Cardiac disorders 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); Diabetes mellitus AE (grade 3-4); Diarrhoea AE (grade 3-4); Dizziness AE (grade 3-4); Dyspnoea AE (grade 3-4); Endocrine disorders AE (grade 3-4); Epistaxis AE (grade 3-4); Erythema AE (grade 3-4); Eye disorders AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Gastritis AE (grade 3-4); Gastrointestinal disorders AE (grade 3-4); General disorders and administration site conditions AE (grade 3-4); Headache AE (grade 3-4); Hepatobiliary disorders (AE grade 3-4); Hypertension AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypophysitis AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Infections and infestations AE (grade 3-4); Injury, poisoning and procedure AE (grade 3-4); Investigations AE (grade 3-4); Leucopenia AE (grade 3-4); Metabolism and nutrition disorders AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Musculoskeletal and connective tissue disorders AE (grade 3-4); Myalgia AE (grade 3-4); Myopathy AE (grade 3-4); Nausea AE (grade 3-4); Nervous system disorders AE (grade 3-4); Neutropenia AE (grade 3-4); Paraesthesia AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Peripheral oedema AE (grade 3-4); Pneumonia AE (grade 3-4); Pneumonitis AE (grade 3-4); Proteinuria AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Renal and urinary disorders AE (grade 3-4); Respiratory, thoracic and mediastinal disorders AE (grade 3-4); Sepsis AE (grade 3-4); Skin and subcutaneous tissue disorders AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Urticaria AE (grade 3-4); Uveitis AE (grade 3-4); Vascular disorders AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4)--

metastatic, hormone-sensitive prostate cancer metastatic, hormone-sensitive prostate cancer