Safety and Tolerability of ODM-201 in Castrate Resistant... | NCT01429064

Label	Type	Description	Intervention Names
ODM-201	Experimental		Drug: ODM-201

Name	Type	Description	Arm Group Labels	Other Names
ODM-201	Drug	ODM-201 administered orally daily	ODM-201

Measure	Description	Time Frame
Number of Participants With Adverse Events	Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.	From first dose of study treatment up to 4 weeks after last dose of study treatment

Name	Affiliation	Role
Karim Fizazi	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Urology Center of Colorado		Wheat Ridge	Colorado	80211	United States
Eastern CT Hematology and Oncology Associates

PubMed Identifier	Type	Citation	Retractions
28753851	Derived	Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.
28753849

ID	Title	Description
FG000	Patients From Arades 3104001 Dose Escalation	200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
FG001	Patients From Arades 3104001 Dose Expansion (200mg/Day)

ID	Title	Description
BG000	Patients From Arades 3104001 Dose Escalation	200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
BG001	Patients From Arades 3104001 Dose Expansion (200mg/Day)	Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
BG002	Patients From Arades 3104001 Dose Expansion (400mg/Day)	Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
BG003	Patients From Arades 3104001 Dose Expansion (1400mg/Day)	Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00019 BG00122 BG00219 BG00316 BG00476

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG0030 affected16 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Ileus paralytic	Gastrointestinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Chills	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Pain	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Diverticulitis	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Enterobacter infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Liver abscess	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Lung infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Stenotrophomonas infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Urosepsis	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Enterobacter test positive	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Cerebral ischaemia	Nervous system disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Syncope	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Confusional state	Psychiatric disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Calculus urinary	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Hydronephrosis	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Urethral stenosis	Renal and urinary disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Lymphoedema	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0022 affected19 at risk EG0031 affected16 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Mitral valve incompetence	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Supraventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Motion sickness	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Eye pain	Eye disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Eye pruritus	Eye disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Eyelid oedema	Eye disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Ocular hyperaemia	Eye disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Periorbital oedema	Eye disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Visual acuity reduced	Eye disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Abnormal faeces	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Anal fissure	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Cheilitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 affected19 at risk EG0013 affected22 at risk EG0023 affected19 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0009 affected19 at risk EG0010 affected22 at risk EG0022 affected19 at risk EG003
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0022 affected19 at risk EG003
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Gingival pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0005 affected19 at risk EG0012 affected22 at risk EG0023 affected19 at risk EG003
Oesophagitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0002 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Tongue discolouration	Gastrointestinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0003 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0005 affected19 at risk EG0011 affected22 at risk EG0022 affected19 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0022 affected19 at risk EG003
Face oedema	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0005 affected19 at risk EG0013 affected22 at risk EG0025 affected19 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Localised oedema	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Malaise	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0003 affected19 at risk EG0012 affected22 at risk EG0021 affected19 at risk EG003
Pain	General disorders	Systematic Assessment	EG0004 affected19 at risk EG0017 affected22 at risk EG0021 affected19 at risk EG003
Peripheral swelling	General disorders	Systematic Assessment	EG0001 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 affected19 at risk EG0012 affected22 at risk EG0021 affected19 at risk EG003
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Eye infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Herpes zoster	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Lower respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0004 affected19 at risk EG0012 affected22 at risk EG0021 affected19 at risk EG003
Onychomycosis	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Oral herpes	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Pyelonephritis acute	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Rhinitis	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Tinea cruris	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Tooth abscess	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Tooth infection	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0003 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Viral infection	Infections and infestations	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected19 at risk EG0012 affected22 at risk EG0021 affected19 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Sunburn	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Blood alkaline phosphatase increased	Investigations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0022 affected19 at risk EG003
Blood creatinine increased	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Blood lactate dehydrogenase increased	Investigations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Blood pressure increased	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Blood urine present	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Cardiac murmur	Investigations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Electrocardiogram PR prolongation	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Electrocardiogram QT prolonged	Investigations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Heart rate increased	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Liver palpable	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Urine output increased	Investigations	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Weight decreased	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Weight increased	Investigations	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Cachexia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected19 at risk EG0013 affected22 at risk EG0025 affected19 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0006 affected19 at risk EG0017 affected22 at risk EG0023 affected19 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 affected19 at risk EG0014 affected22 at risk EG0025 affected19 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Exposed bone in jaw	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0013 affected22 at risk EG0020 affected19 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Joint lock	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0012 affected22 at risk EG0022 affected19 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Ageusia	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Areflexia	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0002 affected19 at risk EG0011 affected22 at risk EG0023 affected19 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0004 affected19 at risk EG0012 affected22 at risk EG0021 affected19 at risk EG003
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Hyporeflexia	Nervous system disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Lethargy	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Monoparesis	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Paraplegia	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Petit mal epilepsy	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Presyncope	Nervous system disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Sciatica	Nervous system disorders	Systematic Assessment	EG0003 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Tremor	Nervous system disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Affective disorder	Psychiatric disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Alcohol abuse	Psychiatric disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Confusional state	Psychiatric disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0002 affected19 at risk EG0011 affected22 at risk EG0023 affected19 at risk EG003
Sleep disorder	Psychiatric disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Bladder dilatation	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Dysuria	Renal and urinary disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0001 affected19 at risk EG0013 affected22 at risk EG0021 affected19 at risk EG003
Haemorrhage urinary tract	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Hydronephrosis	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Lower urinary tract symptoms	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Micturition frequency decreased	Renal and urinary disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Micturition urgency	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Nocturia	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0022 affected19 at risk EG003
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Urinary tract inflammation	Renal and urinary disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Breast tenderness	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	Systematic Assessment	EG0003 affected19 at risk EG0011 affected22 at risk EG0022 affected19 at risk EG003
Pelvic pain	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Penile oedema	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected19 at risk EG0012 affected22 at risk EG0020 affected19 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0021 affected19 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Skin atrophy	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Aortic arteriosclerosis	Vascular disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Circulatory collapse	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Flushing	Vascular disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Hot flush	Vascular disorders	Systematic Assessment	EG0001 affected19 at risk EG0011 affected22 at risk EG0023 affected19 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0002 affected19 at risk EG0012 affected22 at risk EG0022 affected19 at risk EG003
Intermittent claudication	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0011 affected22 at risk EG0020 affected19 at risk EG003
Lymphoedema	Vascular disorders	Systematic Assessment	EG0002 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Pelvic venous thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003
Poor peripheral circulation	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Superficial vein prominence	Vascular disorders	Systematic Assessment	EG0001 affected19 at risk EG0010 affected22 at risk EG0020 affected19 at risk EG003
Lymphostasis	Vascular disorders	Systematic Assessment	EG0000 affected19 at risk EG0010 affected22 at risk EG0021 affected19 at risk EG003

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Patients From Arades 3104001 Dose Escalation	200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day	5	19	19	19
EG001	Patients From Arades 3104001 Dose Expansion (200mg/Day)	Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.	7	22	22	22
EG002	Patients From Arades 3104001 Dose Expansion (400mg/Day)	Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.	3	19	19	19
EG003	Patients From Arades 3104001 Dose Expansion (1400mg/Day)	Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.	4	16	16	16