ID

43648

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00147212

Trefwoorden

  1. 05-06-16 05-06-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00147212

Eligibility Prostate Cancer NCT00147212

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate
Beschrijving

adenocarcinoma of the prostate

Datatype

boolean

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

metastatic disease

Datatype

boolean

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

castration

Datatype

boolean

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

psa

Datatype

boolean

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

crpc

Datatype

boolean

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

taxane-based chemotherapy regimen

Datatype

boolean

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

performance status

Datatype

boolean

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

neutrophil count

Datatype

boolean

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

platelet count

Datatype

boolean

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

serum bilirubin

Datatype

boolean

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

serum alkaline phosphatase

Datatype

boolean

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

asparate aminotransferase/alanine aminotransferase

Datatype

boolean

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

albumin

Datatype

boolean

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

serum creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
prior hormonal therapy
Beschrijving

hormonal therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

chemotherapy treatment

Datatype

boolean

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

contraception

Datatype

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
Beschrijving

comorbidity

Datatype

boolean

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

anti-cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Prostate Cancer NCT00147212

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

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