ID

15600

Description

The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00819247

Link

https://clinicaltrials.gov/show/NCT00819247

Keywords

  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00819247

Eligibility Prostate Cancer NCT00819247

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent before any trial related activity
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
proven prostate cancer with a need for endocrine treatment
Description

prostate cancer with a need for endocrine treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0038900
testosterone level within the normal range for the age
Description

testosterone level

Data type

boolean

Alias
UMLS CUI [1]
C0039601
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or current hormonal treatment of prostate cancer
Description

hormonal treatment of prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
candidate for prostatectomy or radiotherapy
Description

prostatectomy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C1548635
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1548635
history of severe asthma, anaphylactic reactions or quincke's oedema
Description

severe asthma or anaphylactic reactions or quinckes oedema

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C0002792
UMLS CUI [3]
C0002994
hypersensitivity towards any component of fe200486
Description

hypersensitivity towards fe200486

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0971731
cancer disease within the last ten years except for prostate cancer and some skin cancers
Description

other malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
mental incapacity or language barrier
Description

mental incapacity or language barrier

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0237167
having received an investigational product within the last 12 weeks preceding the trial
Description

investigational product

Data type

boolean

Alias
UMLS CUI [1]
C2348568
previous participation in this trial
Description

previous participation in this trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Prostate Cancer NCT00819247

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])

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