ID

22831

Description

Fulvestrant in Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00476645

Link

https://clinicaltrials.gov/show/NCT00476645

Keywords

Versions (1)
  1. 6/12/17 6/12/17 -
Uploaded on

June 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00476645

English

Eligibility Prostatic Neoplasms NCT00476645

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must give signed written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must be of age 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
must be currently receiving lhrh agonists and have castrate levels of testosterone or have had an orchiectomy
Description

Luteinizing Hormone-releasing Hormone Agonist | Testosterone measurement | Orchiectomy

Data type

boolean

Alias
UMLS CUI [1]
C1518041
UMLS CUI [2]
C0523912
UMLS CUI [3]
C0029189
must have had rise in psa despite anti-androgen withdrawal
Description

Raised prostate specific antigen | Androgen Antagonists Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C0002842
UMLS CUI [2,2]
C2349954
must exhibit two consecutive rises in psa after the last hormonal manipulation
Description

Raised prostate specific antigen Quantity Post Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0279025
minimum psa > 5mg/dl
Description

Prostate-Specific Antigen Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C1524031
kps > 80%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
up to one prior chemotherapy treatments allowed
Description

Chemotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
life expectancy of greater than 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concomitant hormonal therapy other than an lhrh
Description

Hormone Therapy | LHRH

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0023610
noncompliance
Description

Non-compliance

Data type

boolean

Alias
UMLS CUI [1]
C0457432
platelets less than 100 x 10e9 /l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
international normalization ratio (inr) greater than 1.6
Description

International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0525032
total bilirubin greater than 1.5 x ulrr
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
alt or ast greater than 2.5 x ulrr if no demonstrable liver metastases or greater than 5.0 x ulrr in presence of liver metastases
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0494165
history of bleeding diathesis (ie, disseminated intravascular coagulation [dic], clotting factor deficiency)
Description

Bleeding tendency | Disseminated Intravascular Coagulation | Clotting factor deficiency

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0012739
UMLS CUI [3]
C0272315
history of long-term anticoagulant therapy (other than antiplatelet therapy)
Description

Anticoagulant therapy Long-term | Antiplatelet therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C0443252
UMLS CUI [2]
C1096021
history of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or mannitol)
Description

Hypersensitivity Fulvestrant Excipient | Hypersensitivity Fulvestrant inactive ingredient | Castor oil allergy | Mannitol allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0935916
UMLS CUI [1,3]
C0015237
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0935916
UMLS CUI [2,3]
C1552019
UMLS CUI [3]
C0571232
UMLS CUI [4]
C0571922
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Similar models

Eligibility Prostatic Neoplasms NCT00476645

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
must give signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
must be of age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Luteinizing Hormone-releasing Hormone Agonist | Testosterone measurement | Orchiectomy
Item
must be currently receiving lhrh agonists and have castrate levels of testosterone or have had an orchiectomy
boolean
C1518041 (UMLS CUI [1])
C0523912 (UMLS CUI [2])
C0029189 (UMLS CUI [3])
Raised prostate specific antigen | Androgen Antagonists Withdrawal
Item
must have had rise in psa despite anti-androgen withdrawal
boolean
C0178415 (UMLS CUI [1])
C0002842 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Raised prostate specific antigen Quantity Post Hormone Therapy
Item
must exhibit two consecutive rises in psa after the last hormonal manipulation
boolean
C0178415 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0279025 (UMLS CUI [1,4])
Prostate-Specific Antigen Minimum
Item
minimum psa > 5mg/dl
boolean
C0138741 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
kps > 80%
boolean
C0206065 (UMLS CUI [1])
Chemotherapy Quantity
Item
up to one prior chemotherapy treatments allowed
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of greater than 6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy | LHRH
Item
concomitant hormonal therapy other than an lhrh
boolean
C0279025 (UMLS CUI [1])
C0023610 (UMLS CUI [2])
Non-compliance
Item
noncompliance
boolean
C0457432 (UMLS CUI [1])
Platelet Count measurement
Item
platelets less than 100 x 10e9 /l
boolean
C0032181 (UMLS CUI [1])
International Normalized Ratio
Item
international normalization ratio (inr) greater than 1.6
boolean
C0525032 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin greater than 1.5 x ulrr
boolean
C0741494 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver
Item
alt or ast greater than 2.5 x ulrr if no demonstrable liver metastases or greater than 5.0 x ulrr in presence of liver metastases
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Bleeding tendency | Disseminated Intravascular Coagulation | Clotting factor deficiency
Item
history of bleeding diathesis (ie, disseminated intravascular coagulation [dic], clotting factor deficiency)
boolean
C1458140 (UMLS CUI [1])
C0012739 (UMLS CUI [2])
C0272315 (UMLS CUI [3])
Anticoagulant therapy Long-term | Antiplatelet therapy
Item
history of long-term anticoagulant therapy (other than antiplatelet therapy)
boolean
C0150457 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C1096021 (UMLS CUI [2])
Hypersensitivity Fulvestrant Excipient | Hypersensitivity Fulvestrant inactive ingredient | Castor oil allergy | Mannitol allergy
Item
history of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or mannitol)
boolean
C0020517 (UMLS CUI [1,1])
C0935916 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0935916 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
C0571232 (UMLS CUI [3])
C0571922 (UMLS CUI [4])
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