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Eligibility Breast Cancer NCT01621425

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is at least 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject is able and willing to sign the informed consent form prior to screening evaluations
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol (tac regimen) or male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (prodoc regimen)
Description

Gender | Breast Carcinoma | docetaxel | TAC Regimen | Secondary malignant neoplasm of prostate Castration Resistance | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0246415
UMLS CUI [4]
C1883257
UMLS CUI [5,1]
C0347001
UMLS CUI [5,2]
C4329620
UMLS CUI [6]
C3846158
subject has a live expectancy of 12 weeks or greater
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
absolute neutrophile count (anc) > 1.5 x 10e9/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100 x 10e9/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine ≤ 2 x uln
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin level < 1.5 x uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
docetaxel treatment within the last year
Description

Docetaxel

Data type

boolean

Alias
UMLS CUI [1]
C0246415
moderate or severe liver impairment; [alat and/or asat ≥ 1.5 uln] and [af ≥ 2.5 uln]
Description

Liver Dysfunction Moderate | Liver Dysfunction Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151849
current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the first docetaxel administration, known to inhibit or induce cyp3a4.
Description

Pharmacotherapy | Dietary Supplements | CYP3A4 Inhibitors | CYP3A4 Inducers

Data type

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0242295
UMLS CUI [3]
C3850053
UMLS CUI [4]
C3850041
inability to understand the nature and extent of the study and the procedures required
Description

Study Protocol Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Breast Cancer NCT01621425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is at least 18
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
subject is able and willing to sign the informed consent form prior to screening evaluations
boolean
C0021430 (UMLS CUI [1])
Gender | Breast Carcinoma | docetaxel | TAC Regimen | Secondary malignant neoplasm of prostate Castration Resistance | Other Coding
Item
female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol (tac regimen) or male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (prodoc regimen)
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
C1883257 (UMLS CUI [4])
C0347001 (UMLS CUI [5,1])
C4329620 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
Life Expectancy
Item
subject has a live expectancy of 12 weeks or greater
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophile count (anc) > 1.5 x 10e9/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100 x 10e9/l
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 2 x uln
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin level < 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Docetaxel
Item
docetaxel treatment within the last year
boolean
C0246415 (UMLS CUI [1])
Liver Dysfunction Moderate | Liver Dysfunction Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
moderate or severe liver impairment; [alat and/or asat ≥ 1.5 uln] and [af ≥ 2.5 uln]
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Pharmacotherapy | Dietary Supplements | CYP3A4 Inhibitors | CYP3A4 Inducers
Item
current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the first docetaxel administration, known to inhibit or induce cyp3a4.
boolean
C0013216 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C3850053 (UMLS CUI [3])
C3850041 (UMLS CUI [4])
Study Protocol Comprehension Unable
Item
inability to understand the nature and extent of the study and the procedures required
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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