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T1  - Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients : Follow-up from the ARADES and ARAFOR Trials 
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UR  - http://hdl.handle.net/10138/299672 
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A1  - Shore, Neal D.; Tammela, Teuvo L.; Massard, Christophe; Bono, P.; Aspegren, John; Mustonen, Mika; Fizazi, Karim 
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Y1  - 2018 
LA  - eng 
AB  - Background: ODM-201, a new androgen receptor antagonist for treatment of metastatic castration-resistant prostate cancer (mCRPC), demonstrated antitumour activity and acceptable tolerability in phase 1/2 trials. Objective: To determine the antitumour activity and safety profile of extended treatment with ODM-201 in men with mCRPC. Design, setting, and participants: ARADES and ARAFOR trials with ODM-201 enrolled chemotherapy-naïve and CYP17 inhibitor (CYP17i)-naïve mCRPC patients. Both trials had... 
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KW  - darolutamide; oxygenase inhibitor; prostate specific antigen, abdominal pain; adult; aged; antineoplastic activity; arthralgia; Article; backache; bone pain; cancer growth; castration resistant prostate cancer; clinical article; constipation; decreased appetite; dermatitis; diarrhea; dizziness; drug safety; drug tolerability; dysgeusia; dysuria; fatigue; femoral neck fracture; follow up; gynecomastia; headache; hematuria; hot flush; human; hypertension; hyponatremia; influenza; limb pain; lung adenocarcinoma; male; metastasis; nausea; neuroendocrine carcinoma; phase 1 clinical trial; phase 2 clinical trial; rash; respiratory failure; rhinopharyngitis; rhinorrhea; side effect; somnolence; tinnitus; urine incontinence; vomiting; 3122 Cancers 
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