Information:
Error:
ID
13036
Description
Adjuvant FEC Versus EP in Breast Cancer (MIG5); ODM derived from: https://clinicaltrials.gov/show/NCT02450058
Link
https://clinicaltrials.gov/show/NCT02450058
Keywords
Versions (1)
- 1/12/16 1/12/16 -
Uploaded on
January 12, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02450058
Eligibility Breast Cancer NCT02450058
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT02450058
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
breast cancer, surgery, lymph node dissection
Item
women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection
boolean
C0678222 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0917927 (UMLS CUI [3])
C0193867 (UMLS CUI [4])
C0024881 (UMLS CUI [2])
C0917927 (UMLS CUI [3])
C0193867 (UMLS CUI [4])
lymph node status
Item
lymph node-positive disease with less than 10 involved axillary lymph nodes
boolean
C0024204 (UMLS CUI [1])
date of surgery
Item
surgery performed not more than 5 weeks before randomization
boolean
C1628561 (UMLS CUI [1])
ecog
Item
ecog performance status 0
boolean
C1520224 (UMLS CUI [1])
absolute neutrophil count
Item
absolute neutrophil count ≥ 2,000/mm³
boolean
C0948762 (UMLS CUI [1])
wbc
Item
wbc ≥ 3,000/mm³
boolean
C0023508 (UMLS CUI [1])
platelet count
Item
platelet count ≥ 100,000/mm³
boolean
C0005821 (UMLS CUI [1])
bilirubin
Item
bilirubin ≤ 1.5 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
ast and alt
Item
ast and alt ≤ 1.5 times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201836 (UMLS CUI [2])
post-op radiotherapy, breast-conserving surgery
Item
postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery
boolean
C1522449 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
C0917927 (UMLS CUI [2])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
invasive breast carcinoma
Item
prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years
boolean
C0678222 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,2])
metastases
Item
metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
boolean
C0027627 (UMLS CUI [1])
prior chemotherapy, hormonal therapy
Item
prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0279025 (UMLS CUI [2])
pregnant or nursing
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Comorbidities
Item
other serious medical illness requiring medication, uncontrolled infections
boolean
C0009488 (UMLS CUI [1])
malignant neoplasms with exceptions
Item
other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0302592 (UMLS CUI [4])
C0553723 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0302592 (UMLS CUI [4])
myocardial infarction, congestive heart failure, or serious arrhythmia
Item
recent myocardial infarction, congestive heart failure, or serious arrhythmia
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0018802 (UMLS CUI [2])
C0003811 (UMLS CUI [3])