ID

16165

Description

Phase II Dasatinib Study in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00546104

Link

https://clinicaltrials.gov/show/NCT00546104

Keywords

  1. 7/3/16 7/3/16 -
Uploaded on

July 3, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Advanced Breast Cancer NCT00546104

Eligibility Advanced Breast Cancer NCT00546104

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
measurable stage iv or inoperable stage iii advanced breast cancer.
Description

breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0678222
there is no limit on the number of prior therapies.
Description

prior therapies

Data type

boolean

Alias
UMLS CUI [1]
C1514463
at least 3 weeks since prior chemotherapy, biological or hormonal therapy
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
at least 2 weeks since surgical biopsy
Description

surgical biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0005558
at least 3 weeks since major (open thoracic/abdominal/cardiac) surgery.
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
no central nervous system (cns) metastases except solitary brain metastasis
Description

central nervous system (cns) metastases

Data type

boolean

Alias
UMLS CUI [1]
C0279130
no cardiac dysfunction
Description

cardiac dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3277906
left ventricular ejection fraction (lvef) ≥ 50% as determined by multiple gated acquisition scan (muga)/echocardiogram
Description

left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
adequate blood counts
Description

blood count

Data type

boolean

Alias
UMLS CUI [1]
C0005771
normal liver and kidney function
Description

normal liver and kidney function

Data type

boolean

Alias
UMLS CUI [1]
C1848676
UMLS CUI [2]
C0232805
negative serum pregnancy test.
Description

negative serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0430061
able to provide informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding.
Description

pregnant or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
prior treatment with dasatinib.
Description

dasatinib

Data type

boolean

Alias
UMLS CUI [1]
C1455147
bone as the only site of disease.
Description

bone disease

Data type

boolean

Alias
UMLS CUI [1]
C0005940
significant gastrointestinal bleeding
Description

gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0017181
septicemia, infection, acute hepatitis, hypokalemia, or hypomagnesemia
Description

septicemia, acute hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0036690
UMLS CUI [2]
C0267797

Similar models

Eligibility Advanced Breast Cancer NCT00546104

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
breast cancer
Item
measurable stage iv or inoperable stage iii advanced breast cancer.
boolean
C0678222 (UMLS CUI [1])
prior therapies
Item
there is no limit on the number of prior therapies.
boolean
C1514463 (UMLS CUI [1])
chemotherapy
Item
at least 3 weeks since prior chemotherapy, biological or hormonal therapy
boolean
C0392920 (UMLS CUI [1])
surgical biopsy
Item
at least 2 weeks since surgical biopsy
boolean
C0005558 (UMLS CUI [1])
major surgery
Item
at least 3 weeks since major (open thoracic/abdominal/cardiac) surgery.
boolean
C0679637 (UMLS CUI [1])
central nervous system (cns) metastases
Item
no central nervous system (cns) metastases except solitary brain metastasis
boolean
C0279130 (UMLS CUI [1])
cardiac dysfunction
Item
no cardiac dysfunction
boolean
C3277906 (UMLS CUI [1])
left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) ≥ 50% as determined by multiple gated acquisition scan (muga)/echocardiogram
boolean
C0428772 (UMLS CUI [1])
blood count
Item
adequate blood counts
boolean
C0005771 (UMLS CUI [1])
normal liver and kidney function
Item
normal liver and kidney function
boolean
C1848676 (UMLS CUI [1])
C0232805 (UMLS CUI [2])
negative serum pregnancy test
Item
negative serum pregnancy test.
boolean
C0430061 (UMLS CUI [1])
informed consent
Item
able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or breast feeding
Item
pregnant or breast feeding.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
dasatinib
Item
prior treatment with dasatinib.
boolean
C1455147 (UMLS CUI [1])
bone disease
Item
bone as the only site of disease.
boolean
C0005940 (UMLS CUI [1])
gastrointestinal bleeding
Item
significant gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1])
septicemia, acute hepatitis
Item
septicemia, infection, acute hepatitis, hypokalemia, or hypomagnesemia
boolean
C0036690 (UMLS CUI [1])
C0267797 (UMLS CUI [2])

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