Information:
Error:
ID
12964
Description
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193063
Link
https://clinicaltrials.gov/show/NCT00193063
Keywords
Versions (1)
- 1/7/16 1/7/16 -
Uploaded on
January 7, 2016
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Breast Cancer NCT00193063
Eligibility Breast Cancer NCT00193063
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00193063
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
biopsy metastasis, her2
Item
her-2 positive metastatic breast cancer confirmed by biopsy
boolean
C0005558 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0242957 (UMLS CUI [2])
C0027627 (UMLS CUI [1,2])
C0242957 (UMLS CUI [2])
measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
performance status
Item
able to perform activities of daily living without considerable
boolean
C1518965 (UMLS CUI [1])
gemcitabine
Item
no previous chemotherapy with gemcitabine
boolean
C0045093 (UMLS CUI [1])
chemotherapy
Item
no more than one prior chemotherapy regimen for metastatic breast cancer
boolean
C0392920 (UMLS CUI [1])
bone marrow, liver and renal function
Item
adequate bone marrow, liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0005953 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
cardiac function
Item
normal heart function
boolean
C0232164 (UMLS CUI [1])
informed consent
Item
give written informed consent prior to entering this study.
boolean
C0021430 (UMLS CUI [1])
gemcitabine
Item
received previous treatment with gemcitabine
boolean
C0045093 (UMLS CUI [1])
brain metastases
Item
history of brain metastases
boolean
C0220650 (UMLS CUI [1])
comorbidity
Item
serious underlying medical conditions
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
additional inclusion/exclusion criteria
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean