ID

31656

Beschrijving

Window Study of ZD4054 in Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01168141

Link

https://clinicaltrials.gov/show/NCT01168141

Trefwoorden

Versies (1)
  1. 17-09-18 17-09-18 -
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See clinicaltrials.gov

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17 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01168141

Engels

Eligibility Prostate Cancer NCT01168141

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological confirmation of prostate adenocarcinoma
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
documented evidence of bone metastasis on bone scan or mri
Beschrijving

Secondary malignant neoplasm of bone Bone scan | Secondary malignant neoplasm of bone MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C0024485
biochemical progression of prostate cancer
Beschrijving

Prostate carcinoma Progression Biochemical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C0205474
surgically or medically castrate with serum testosterone ≤2.4nmol/l
Beschrijving

Male Castration | Medical Castration | Serum testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2]
C1513054
UMLS CUI [3]
C0428413
ecog performance status 0 - 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of 6 months or more.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
Beschrijving

Therapeutic radiology procedure Bone lesion | Therapeutic radiology procedure Prostate Bed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0238792
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C2983573
prior targeted cancer therapies (such as gefitinib, bevacizumab)
Beschrijving

Targeted cancer therapy | gefitinib | bevacizumab

Datatype

boolean

Alias
UMLS CUI [1]
C3854476
UMLS CUI [2]
C1122962
UMLS CUI [3]
C0796392
systemic radionuclide therapy within 12 weeks of starting study treatment.
Beschrijving

Radionuclide therapy Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0203608
UMLS CUI [1,2]
C0205373
current therapy, within 4 weeks of study entry with potent inhibitors of cyp3a4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of cyps 2d6 and 2c9 (quinidine and fluconazole), and potent p450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
Beschrijving

CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Erythromycin | Troleandomycin | Clarithromycin | Diltiazem | Verapamil | CYP2D6 Inhibitors | CYP2C9 Inhibitors | Quinidine | Fluconazole | Cytochrome P450 Inducer | Phenytoin | Rifampin | Carbamazepine | Phenobarbital

Datatype

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0064113
UMLS CUI [4]
C0292818
UMLS CUI [5]
C0376637
UMLS CUI [6]
C0014806
UMLS CUI [7]
C0041165
UMLS CUI [8]
C0055856
UMLS CUI [9]
C0012373
UMLS CUI [10]
C0042523
UMLS CUI [11]
C3850058
UMLS CUI [12]
C3850060
UMLS CUI [13]
C0034414
UMLS CUI [14]
C0016277
UMLS CUI [15,1]
C0010762
UMLS CUI [15,2]
C3898767
UMLS CUI [16]
C0031507
UMLS CUI [17]
C0035608
UMLS CUI [18]
C0006949
UMLS CUI [19]
C0031412
definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
Beschrijving

Medical History Adverse reaction to drug | Family history Adverse reaction to drug | Medical History Adverse reaction to drug Suspected | Family history Adverse reaction to drug Suspected | Hypersensitivity Endothelin antagonist

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0041755
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0041755
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0041755
UMLS CUI [3,3]
C0750491
UMLS CUI [4,1]
C0241889
UMLS CUI [4,2]
C0041755
UMLS CUI [4,3]
C0750491
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1134681
ineligibility for mri scanning includes standard mri criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based mri contrast agents
Beschrijving

Ineligibility MRI scan | Metallic implant | Cochlear Implants | Artificial cardiac pacemaker | Heart Valve | Aneurysm clip | Metal foreign body in eye region | Hypersensitivity Gadolinium-based Contrast Agent MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C3693688
UMLS CUI [3]
C0009199
UMLS CUI [4]
C0030163
UMLS CUI [5]
C0018825
UMLS CUI [6]
C0179977
UMLS CUI [7]
C0562528
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C3249258
UMLS CUI [8,3]
C0024485
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Similar models

Eligibility Prostate Cancer NCT01168141

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histological confirmation of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
Secondary malignant neoplasm of bone Bone scan | Secondary malignant neoplasm of bone MRI
Item
documented evidence of bone metastasis on bone scan or mri
boolean
C0153690 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Prostate carcinoma Progression Biochemical
Item
biochemical progression of prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0205474 (UMLS CUI [1,3])
Male Castration | Medical Castration | Serum testosterone measurement
Item
surgically or medically castrate with serum testosterone ≤2.4nmol/l
boolean
C0007347 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0428413 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of 6 months or more.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Bone lesion | Therapeutic radiology procedure Prostate Bed
Item
radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
boolean
C1522449 (UMLS CUI [1,1])
C0238792 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C2983573 (UMLS CUI [2,2])
Targeted cancer therapy | gefitinib | bevacizumab
Item
prior targeted cancer therapies (such as gefitinib, bevacizumab)
boolean
C3854476 (UMLS CUI [1])
C1122962 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
Radionuclide therapy Systemic
Item
systemic radionuclide therapy within 12 weeks of starting study treatment.
boolean
C0203608 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Erythromycin | Troleandomycin | Clarithromycin | Diltiazem | Verapamil | CYP2D6 Inhibitors | CYP2C9 Inhibitors | Quinidine | Fluconazole | Cytochrome P450 Inducer | Phenytoin | Rifampin | Carbamazepine | Phenobarbital
Item
current therapy, within 4 weeks of study entry with potent inhibitors of cyp3a4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of cyps 2d6 and 2c9 (quinidine and fluconazole), and potent p450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0376637 (UMLS CUI [5])
C0014806 (UMLS CUI [6])
C0041165 (UMLS CUI [7])
C0055856 (UMLS CUI [8])
C0012373 (UMLS CUI [9])
C0042523 (UMLS CUI [10])
C3850058 (UMLS CUI [11])
C3850060 (UMLS CUI [12])
C0034414 (UMLS CUI [13])
C0016277 (UMLS CUI [14])
C0010762 (UMLS CUI [15,1])
C3898767 (UMLS CUI [15,2])
C0031507 (UMLS CUI [16])
C0035608 (UMLS CUI [17])
C0006949 (UMLS CUI [18])
C0031412 (UMLS CUI [19])
Medical History Adverse reaction to drug | Family history Adverse reaction to drug | Medical History Adverse reaction to drug Suspected | Family history Adverse reaction to drug Suspected | Hypersensitivity Endothelin antagonist
Item
definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
boolean
C0262926 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0041755 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0041755 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
C0241889 (UMLS CUI [4,1])
C0041755 (UMLS CUI [4,2])
C0750491 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C1134681 (UMLS CUI [5,2])
Ineligibility MRI scan | Metallic implant | Cochlear Implants | Artificial cardiac pacemaker | Heart Valve | Aneurysm clip | Metal foreign body in eye region | Hypersensitivity Gadolinium-based Contrast Agent MRI
Item
ineligibility for mri scanning includes standard mri criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based mri contrast agents
boolean
C1512714 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2])
C0009199 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C0018825 (UMLS CUI [5])
C0179977 (UMLS CUI [6])
C0562528 (UMLS CUI [7])
C0020517 (UMLS CUI [8,1])
C3249258 (UMLS CUI [8,2])
C0024485 (UMLS CUI [8,3])
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