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ID
17236
Beschrijving
Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00280930
Link
https://clinicaltrials.gov/show/NCT00280930
Trefwoorden
Versies (1)
- 01-09-16 01-09-16 -
Geüploaded op
1 september 2016
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Post-Menopausal NCT00280930
Eligibility Post-Menopausal NCT00280930
- StudyEvent: Eligibility
Similar models
Eligibility Post-Menopausal NCT00280930
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
postmenopausal status; no spontaneous menses; fsh level; bilateral oophorectomy
Item
postmenopausal status defined as: women >55 years of age-no spontaneous menses for at least 12 months; in women < 55 years-no spontaneous menses within the past 12 months and with an fsh level >34.4 iu/i; bilateral oophorectomy
boolean
C0232970 (UMLS CUI [1])
C0025344 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0025344 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
prior invasive breast cancer must have been surgically removed with no evidence of metastases
Item
if subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal
boolean
C0853879 (UMLS CUI [1,1])
C1521996 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C1521996 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
mammographic density
Item
baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue
boolean
C1268717 (UMLS CUI [1])
baseline breast examination demonstrating no clinical evidence of breast cancer
Item
baseline breast examination demonstrating no clinical evidence of breast cancer
boolean
C1276755 (UMLS CUI [1])
Dexa scan
Item
acceptable quality dexa of the l2-l4 postero-anterior (pa) spine and hup must be performed 6 months of randomization
boolean
C1510486 (UMLS CUI [1])
Compliance behaviour
Item
subject is willing and able to complete the quality of life questionnaire in either english or french
boolean
C1321605 (UMLS CUI [1])
Mammogram suspicious for breast cancer
Item
mammogram suspicious for breast cancer (unless subsequently ruled out)
boolean
C1277190 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,2])
Malignancies, metastatic disease
Item
patient's with prior malignancies are eligible unless they have metastatic disease
boolean
C0006826 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0027627 (UMLS CUI [2])
uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
Item
uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
boolean
C0025517 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
C0014130 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
chemotherapy or immunotherapy
Item
current chemotherapy or immunotherapy
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0021083 (UMLS CUI [2])
Hormone replacement therapy or evista (raloxifene)
Item
hormone replacement therapy or evista (raloxifene) discontinued less than three months before baseline mammogram
boolean
C0282402 (UMLS CUI [1])
C0618111 (UMLS CUI [2])
C0618111 (UMLS CUI [2])
Tamoxifen
Item
tamoxifen therapy discontinued less than six months prior to randomization
boolean
C0039286 (UMLS CUI [1])