informed consent
Item
signed informed consent before any trial related activity
boolean
C0021430 (UMLS CUI [1])
prostate cancer with a need for endocrine treatment
Item
proven prostate cancer with a need for endocrine treatment
boolean
C0600139 (UMLS CUI [1,1])
C0038900 (UMLS CUI [1,2])
testosterone level
Item
testosterone level within the normal range for the age
boolean
C0039601 (UMLS CUI [1])
hormonal treatment of prostate cancer
Item
previous or current hormonal treatment of prostate cancer
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
prostatectomy or radiotherapy
Item
candidate for prostatectomy or radiotherapy
boolean
C0033573 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
severe asthma or anaphylactic reactions or quinckes oedema
Item
history of severe asthma, anaphylactic reactions or quincke's oedema
boolean
C0581126 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
C0002994 (UMLS CUI [3])
hypersensitivity towards fe200486
Item
hypersensitivity towards any component of fe200486
boolean
C0020517 (UMLS CUI [1,1])
C0971731 (UMLS CUI [1,2])
other malignancy
Item
cancer disease within the last ten years except for prostate cancer and some skin cancers
boolean
C0006826 (UMLS CUI [1])
comorbidity
Item
presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. in addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
boolean
C0009488 (UMLS CUI [1])
mental incapacity or language barrier
Item
mental incapacity or language barrier
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0237167 (UMLS CUI [2])
investigational product
Item
having received an investigational product within the last 12 weeks preceding the trial
boolean
C2348568 (UMLS CUI [1])
previous participation in this trial
Item
previous participation in this trial
boolean
C2348568 (UMLS CUI [1])