ID

19665

Description

A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02443467

Link

https://clinicaltrials.gov/show/NCT02443467

Keywords

  1. 1/20/17 1/20/17 -
Uploaded on

January 20, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer, Early Breast Cancer NCT02443467

Eligibility Breast Cancer, Early Breast Cancer NCT02443467

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients > or = 18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
human epidermal growth factor receptor 2 (her2)-neu overexpression
Description

ERBB2 Protein Overexpression

Data type

boolean

Alias
UMLS CUI [1]
C1515560
previously treated with adjuvant antracycline containing chemotherapy
Description

Adjuvant Chemotherapy Anthracyclines Containing

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0282564
UMLS CUI [1,3]
C0332256
left ventricular ejection fraction (lvef) > 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
eastern cooperative oncology group (ecog) score < or = 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > or = 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
left ventricular ejection fraction (lvef) < 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
advanced pulmonary disease
Description

Lung disease Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205179
severe dyspnea
Description

Dyspnea Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0205082
abnormal laboratory results within 14 days prior to registration
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
peripheral neuropathy
Description

Peripheral Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
presence of central nervous system (cns) metastasis
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377

Similar models

Eligibility Breast Cancer, Early Breast Cancer NCT02443467

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients > or = 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ERBB2 Protein Overexpression
Item
human epidermal growth factor receptor 2 (her2)-neu overexpression
boolean
C1515560 (UMLS CUI [1])
Adjuvant Chemotherapy Anthracyclines Containing
Item
previously treated with adjuvant antracycline containing chemotherapy
boolean
C0085533 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) > 50%
boolean
C0428772 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score < or = 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > or = 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) < 50%
boolean
C0428772 (UMLS CUI [1])
Lung disease Advanced
Item
advanced pulmonary disease
boolean
C0024115 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Dyspnea Severe
Item
severe dyspnea
boolean
C0013404 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Laboratory test result abnormal
Item
abnormal laboratory results within 14 days prior to registration
boolean
C0438215 (UMLS CUI [1])
Peripheral Neuropathy
Item
peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
CNS metastases
Item
presence of central nervous system (cns) metastasis
boolean
C0686377 (UMLS CUI [1])

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