ID

33896

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01509625

Stichworte

  1. 06.01.19 06.01.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. Januar 2019

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Informed Consent

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Postmenopausal state

Datentyp

boolean

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

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Datentyp

boolean

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

Primary tumor Estrogen receptor positive

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Drugs, Non-Prescription | Investigational New Drugs

Datentyp

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.
Beschreibung

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

Datentyp

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

Ähnliche Modelle

Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

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