ID

43648

Description

ET 743 (Yondelis) in Men With Advanced Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00147212

Link

https://clinicaltrials.gov/show/NCT00147212

Keywords

  1. 6/5/16 6/5/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostate Cancer NCT00147212

Eligibility Prostate Cancer NCT00147212

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate
Description

adenocarcinoma of the prostate

Data type

boolean

Alias
UMLS CUI [1]
C0600139
radiographically documented metastatic disease
Description

metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0027627
surgical or chemical castration
Description

castration

Data type

boolean

Alias
UMLS CUI [1]
C0007347
prostate specific antigen (psa) > 5 ng/ml
Description

psa

Data type

boolean

Alias
UMLS CUI [1]
C0138741
castration resistant prostate cancer (crpc)
Description

crpc

Data type

boolean

Alias
UMLS CUI [1]
C1328504
one previous taxane-based chemotherapy regimen
Description

taxane-based chemotherapy regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0215136
eastern cooperative group (ecog) performance status 0,1 or 2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
neutrophil count > 1,500/ul
Description

neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
platelet count > 100,000/ul
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
serum bilirubin < 1.0 x upper limit normal (uln)
Description

serum bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum alkaline phosphatase < 1.5 x uln
Description

serum alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
asparate aminotransferase/alanine aminotransferase < 2.5 x uln
Description

asparate aminotransferase/alanine aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C3831581
albumin > 2.5 g/dl
Description

albumin

Data type

boolean

Alias
UMLS CUI [1]
C0001924
serum creatinine < 1.5 x uln
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
prior hormonal therapy
Description

hormonal therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy treatment within 4 weeks of study entry
Description

chemotherapy treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patient not employing adequate contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis b, c or cirrhosis
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
current anti-cancer treatment with any non-fda approved investigational drug
Description

anti-cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Prostate Cancer NCT00147212

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
adenocarcinoma of the prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0600139 (UMLS CUI [1])
metastatic disease
Item
radiographically documented metastatic disease
boolean
C0027627 (UMLS CUI [1])
castration
Item
surgical or chemical castration
boolean
C0007347 (UMLS CUI [1])
psa
Item
prostate specific antigen (psa) > 5 ng/ml
boolean
C0138741 (UMLS CUI [1])
crpc
Item
castration resistant prostate cancer (crpc)
boolean
C1328504 (UMLS CUI [1])
taxane-based chemotherapy regimen
Item
one previous taxane-based chemotherapy regimen
boolean
C0392920 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
performance status
Item
eastern cooperative group (ecog) performance status 0,1 or 2
boolean
C1520224 (UMLS CUI [1])
neutrophil count
Item
neutrophil count > 1,500/ul
boolean
C0200633 (UMLS CUI [1])
platelet count
Item
platelet count > 100,000/ul
boolean
C0005821 (UMLS CUI [1])
serum bilirubin
Item
serum bilirubin < 1.0 x upper limit normal (uln)
boolean
C1278039 (UMLS CUI [1])
serum alkaline phosphatase
Item
serum alkaline phosphatase < 1.5 x uln
boolean
C0201850 (UMLS CUI [1])
asparate aminotransferase/alanine aminotransferase
Item
asparate aminotransferase/alanine aminotransferase < 2.5 x uln
boolean
C3831581 (UMLS CUI [1])
albumin
Item
albumin > 2.5 g/dl
boolean
C0001924 (UMLS CUI [1])
serum creatinine
Item
serum creatinine < 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
hormonal therapy
Item
prior hormonal therapy
boolean
C0279025 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy treatment
Item
chemotherapy treatment within 4 weeks of study entry
boolean
C0392920 (UMLS CUI [1])
contraception
Item
patient not employing adequate contraception
boolean
C0700589 (UMLS CUI [1])
comorbidity
Item
serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis b, c or cirrhosis
boolean
C0009488 (UMLS CUI [1])
anti-cancer treatment
Item
current anti-cancer treatment with any non-fda approved investigational drug
boolean
C2348568 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial