ID

13036

Beskrivning

Adjuvant FEC Versus EP in Breast Cancer (MIG5); ODM derived from: https://clinicaltrials.gov/show/NCT02450058

Länk

https://clinicaltrials.gov/show/NCT02450058

Nyckelord

  1. 2016-01-12 2016-01-12 -
Uppladdad den

12 januari 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02450058

Eligibility Breast Cancer NCT02450058

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection
Beskrivning

breast cancer, surgery, lymph node dissection

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0024881
UMLS CUI [3]
C0917927
UMLS CUI [4]
C0193867
lymph node-positive disease with less than 10 involved axillary lymph nodes
Beskrivning

lymph node status

Datatyp

boolean

Alias
UMLS CUI [1]
C0024204
surgery performed not more than 5 weeks before randomization
Beskrivning

date of surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C1628561
ecog performance status 0
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count ≥ 2,000/mm³
Beskrivning

absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
wbc ≥ 3,000/mm³
Beskrivning

wbc

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
platelet count ≥ 100,000/mm³
Beskrivning

platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
bilirubin ≤ 1.5 times upper limit of normal (uln)
Beskrivning

bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
ast and alt ≤ 1.5 times uln
Beskrivning

ast and alt

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery
Beskrivning

post-op radiotherapy, breast-conserving surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0917927
written informed consent
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years
Beskrivning

invasive breast carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205281
metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
Beskrivning

metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy
Beskrivning

prior chemotherapy, hormonal therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
pregnant or nursing
Beskrivning

pregnant or nursing

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other serious medical illness requiring medication, uncontrolled infections
Beskrivning

Comorbidities

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
Beskrivning

malignant neoplasms with exceptions

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0302592
recent myocardial infarction, congestive heart failure, or serious arrhythmia
Beskrivning

myocardial infarction, congestive heart failure, or serious arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0003811

Similar models

Eligibility Breast Cancer NCT02450058

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
pregnant or nursing
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
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])
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])

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