Information:
Error:
ID
14823
Description
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01597388
Link
https://clinicaltrials.gov/show/NCT01597388
Keywords
Versions (1)
- 4/29/16 4/29/16 -
Uploaded on
April 29, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Advanced Metastatic Breast Cancer NCT01597388
Eligibility Advanced Metastatic Breast Cancer NCT01597388
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Metastatic Breast Cancer NCT01597388
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
informed consent
Item
provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis
boolean
C0021430 (UMLS CUI [1])
age
Item
aged at least 18
boolean
C0001779 (UMLS CUI [1])
measurable lesion
Item
at least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (ct) magnetic resonance imaging (mri) or plain x-ray and is suitable for repeated assessment
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,2])
ID.4
Item
histological or cytological confirmation of an er+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant
boolean
C2938924 (UMLS CUI [1])
ecog
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
non-child-bearing potential
Item
patients must have evidence of non-child-bearing potential.
boolean
C1960468 (UMLS CUI [1])
chemotherapy
Item
prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites)
boolean
C0392920 (UMLS CUI [1])
major surgery
Item
major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study.
boolean
C0679637 (UMLS CUI [1])
cardiac condition
Item
patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.
boolean
C0018799 (UMLS CUI [1])
Diabetes type 1
Item
patients with diabetes type 1 or uncontrolled type ii (hba1c > 8% assessed locally)
boolean
C0011854 (UMLS CUI [1])