Informed Consent
Item
patient has given written informed consent before any trial-related activity is performed.
boolean
C0021430 (UMLS CUI [1])
Prostate carcinoma | Therapeutic procedure Type Required
Item
has a confirmed prostate cancer in which this type of treatment is needed.
boolean
C0600139 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Prior Therapy Prostate carcinoma
Item
previous treatment for prostate cancer
boolean
C1514463 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Transurethral Resection of Prostate Previous
Item
previous trans-urethral resection of the prostate
boolean
C0040771 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Lymph node positive | Neoplasm Metastasis Other
Item
patients who are lymph node positive or have other metastatic disease
boolean
C0746319 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Use of Urethral Catheter
Item
use of urethral catheter
boolean
C1524063 (UMLS CUI [1,1])
C0179800 (UMLS CUI [1,2])
5-alpha Reductase Inhibitors | Alpha-Adrenergic Receptor antagonist
Item
current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
boolean
C2936788 (UMLS CUI [1])
C2932393 (UMLS CUI [2,1])
C0243076 (UMLS CUI [2,2])
Severe asthma untreated | Anaphylaxis | Urticaria Severe | Angioedema
Item
history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
boolean
C0581126 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2])
C0042109 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002994 (UMLS CUI [4])
Hypersensitivity Investigational New Drug Component
Item
hypersensitivity towards any component of the investigational product
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Cancer Other | Exception Prostate carcinoma | Exception Skin carcinoma Type Some
Item
other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0332307 (UMLS CUI [3,3])
C0205392 (UMLS CUI [3,4])
Risk factors Cardiac Arrhythmia | Risk factors Prolonged QT interval | Prolonged QTc | Torsades de Pointes | Medication Risk
Item
certain risk factors for abnormal heart rhythms/qt prolongation (corrected qt interval over 450 msec., torsades de pointes or use of certain medications with potential risk)
boolean
C0035648 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0151878 (UMLS CUI [2,2])
C1969409 (UMLS CUI [3])
C0040479 (UMLS CUI [4])
C0184544 (UMLS CUI [5])
Disease | Exception Prostate carcinoma | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Heart Diseases | Nervous system disorder | Mental disorders | Substance Use Disorders
Item
clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
boolean
C0012634 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0038586 (UMLS CUI [10])