ID

16920

Beschrijving

Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00263588

Link

https://clinicaltrials.gov/show/NCT00263588

Trefwoorden

  1. 14-08-16 14-08-16 -
Geüploaded op

14 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Neoplasms, Breast NCT00263588

Eligibility Neoplasms, Breast NCT00263588

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
erbb2(her2)overexpressing breast cancer.
Beschrijving

HER2-positive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C1960398
brain lesion(s) which are progressing.
Beschrijving

Brain metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
prior treatment of brain metastases with whole brain radiotherapy (wbr)and/or stereotactic radiosurgery (srs).
Beschrijving

Treatment of brain metastases with whole brain radiotherapy and/or stereotactic radiosurgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C1520143
UMLS CUI [1,2]
C0220650
UMLS CUI [2,1]
C0085203
UMLS CUI [2,2]
C0220650
prior treatment with trastuzumab (herceptin), either alone or in combination with chemotherapy.
Beschrijving

Trastuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0338204
cardiac ejection fraction(lvef)within the institutional range of normal as measured by echocardiogram.
Beschrijving

Cardiac ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
able to swallow an oral medication.
Beschrijving

Able to swallow

Datatype

boolean

Alias
UMLS CUI [1]
C2712086
adequate kidney and liver function.
Beschrijving

Kidney and liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
adequate bone marrow function.
Beschrijving

Bone marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0005953
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females.
Beschrijving

pregnant or lactating

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
conditions that would effect the absorption of an oral drug.
Beschrijving

conditions that would effect the absorption of an oral drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678745
UMLS CUI [1,2]
C0001563
history of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
Beschrijving

Hypersensitivity to gadolinium contrast agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3249258
pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
Beschrijving

Cerebrovascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007820
serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Beschrijving

Medical or psychiatric disorder that would interfere with patient safety or informed consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0009488

Similar models

Eligibility Neoplasms, Breast NCT00263588

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
HER2-positive carcinoma of breast
Item
erbb2(her2)overexpressing breast cancer.
boolean
C1960398 (UMLS CUI [1])
Brain metastases
Item
brain lesion(s) which are progressing.
boolean
C0220650 (UMLS CUI [1])
Treatment of brain metastases with whole brain radiotherapy and/or stereotactic radiosurgery
Item
prior treatment of brain metastases with whole brain radiotherapy (wbr)and/or stereotactic radiosurgery (srs).
boolean
C1520143 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0085203 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
Trastuzumab
Item
prior treatment with trastuzumab (herceptin), either alone or in combination with chemotherapy.
boolean
C0338204 (UMLS CUI [1])
Cardiac ejection fraction
Item
cardiac ejection fraction(lvef)within the institutional range of normal as measured by echocardiogram.
boolean
C0428772 (UMLS CUI [1])
Able to swallow
Item
able to swallow an oral medication.
boolean
C2712086 (UMLS CUI [1])
Kidney and liver function
Item
adequate kidney and liver function.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Bone marrow function
Item
adequate bone marrow function.
boolean
C0005953 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or lactating
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
conditions that would effect the absorption of an oral drug
Item
conditions that would effect the absorption of an oral drug.
boolean
C0678745 (UMLS CUI [1,1])
C0001563 (UMLS CUI [1,2])
Hypersensitivity to gadolinium contrast agents
Item
history of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
boolean
C0020517 (UMLS CUI [1,1])
C3249258 (UMLS CUI [1,2])
Cerebrovascular disease
Item
pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
boolean
C0007820 (UMLS CUI [1])
Medical or psychiatric disorder that would interfere with patient safety or informed consent
Item
serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])

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