ID

33896

Description

Retrospective Study Assessment Treatment Response Faslodex®( 500 mg); ODM derived from: https://clinicaltrials.gov/show/NCT01509625

Link

https://clinicaltrials.gov/show/NCT01509625

Keywords

Versions (1)
  1. 1/6/19 1/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 6, 2019

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.

Back to model comments
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 Malignant Neoplasm of Breast Stage IV NCT01509625

English

Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent from patients when possible.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
in the event of patients who are deceased at the time of inclusion, no signed informed consent will be available; thus, the investigator assumes the responsibility of data protection and confidentiality and of safeguarding the processing of the data.
Description

Patient Deceased | Informed Consent Unavailable | Data Protection | Confidential patient data held | Protection Data Processing

Data type

boolean

Alias
UMLS CUI [1]
C1555024
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0686905
UMLS CUI [3]
C0086099
UMLS CUI [4]
C0422743
UMLS CUI [5,1]
C1545588
UMLS CUI [5,2]
C0868941
post-menopausal women.
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
diagnosed with locally advanced or metastatic breast cancer with histological/cytological confirmation.
Description

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
documented estrogen receptor positive status for the primary tumour.
Description

Primary tumor Estrogen receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0279754
patient who, after progression with a previous anti-estrogen treatment, received treatment at some time with fulvestrant (faslodex®) at the 500 mg/month and ld-500 dose during the study period.
Description

Prior antiestrogen therapy | Disease Progression | Fulvestrant Dose per month | Faslodex Dose per month | Fulvestrant Loading dose | Faslodex Loading dose

Data type

boolean

Alias
UMLS CUI [1]
C0279797
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0935916
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0332177
UMLS CUI [4,1]
C0701491
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0332177
UMLS CUI [5,1]
C0935916
UMLS CUI [5,2]
C3714444
UMLS CUI [6,1]
C0701491
UMLS CUI [6,2]
C3714444
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
having received treatment with unapproved or experimental drugs during the study period.
Description

Drugs, Non-Prescription | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
presenting another concomitant cancer other than stage i cervical cancer or cutaneous tumours without lymph node or distant involvement.
Description

Cancer Other | Exception Cervical cancer Stage | Exception Skin Neoplasms Without Lymph Node Involvement | Exception Skin Neoplasms Without Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C4048328
UMLS CUI [2,3]
C1306673
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0037286
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C0806692
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0037286
UMLS CUI [4,3]
C0332288
UMLS CUI [4,4]
C1269798
Back to the top of the page

Similar models

Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent from patients when possible.
boolean
C0021430 (UMLS CUI [1])
Patient Deceased | Informed Consent Unavailable | Data Protection | Confidential patient data held | Protection Data Processing
Item
in the event of patients who are deceased at the time of inclusion, no signed informed consent will be available; thus, the investigator assumes the responsibility of data protection and confidentiality and of safeguarding the processing of the data.
boolean
C1555024 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
C0086099 (UMLS CUI [3])
C0422743 (UMLS CUI [4])
C1545588 (UMLS CUI [5,1])
C0868941 (UMLS CUI [5,2])
Postmenopausal state
Item
post-menopausal women.
boolean
C0232970 (UMLS CUI [1])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
diagnosed with locally advanced or metastatic breast cancer with histological/cytological confirmation.
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Primary tumor Estrogen receptor positive
Item
documented estrogen receptor positive status for the primary tumour.
boolean
C0677930 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
Prior antiestrogen therapy | Disease Progression | Fulvestrant Dose per month | Faslodex Dose per month | Fulvestrant Loading dose | Faslodex Loading dose
Item
patient who, after progression with a previous anti-estrogen treatment, received treatment at some time with fulvestrant (faslodex®) at the 500 mg/month and ld-500 dose during the study period.
boolean
C0279797 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0935916 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0332177 (UMLS CUI [3,3])
C0701491 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0332177 (UMLS CUI [4,3])
C0935916 (UMLS CUI [5,1])
C3714444 (UMLS CUI [5,2])
C0701491 (UMLS CUI [6,1])
C3714444 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription | Investigational New Drugs
Item
having received treatment with unapproved or experimental drugs during the study period.
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Cancer Other | Exception Cervical cancer Stage | Exception Skin Neoplasms Without Lymph Node Involvement | Exception Skin Neoplasms Without Distant metastasis
Item
presenting another concomitant cancer other than stage i cervical cancer or cutaneous tumours without lymph node or distant involvement.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C4048328 (UMLS CUI [2,2])
C1306673 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0037286 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C0806692 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0037286 (UMLS CUI [4,2])
C0332288 (UMLS CUI [4,3])
C1269798 (UMLS CUI [4,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial