ID

38245

Description

Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01239745

Link

https://clinicaltrials.gov/show/NCT01239745

Keywords

Versions (1)
  1. 10/1/19 10/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 1, 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 Breast Neoplasms NCT01239745

English

Eligibility Breast Neoplasms NCT01239745

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal females, defined as one from the next :
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
1. natural menopause ≥1 year,
Description

Menopause Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0567312
UMLS CUI [1,2]
C0449238
2. surgical ovariectomy,
Description

Ovariectomy

Data type

boolean

Alias
UMLS CUI [1]
C0029936
3. chemotherapy-induced amenorrhoea ≥ 2 years.
Description

Amenorrhea Chemotherapy Induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205263
patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
Description

Operative Surgical Procedure Breast Carcinoma | Neoplasm Metastasis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment.
Description

Disease Free Duration | Status post Adjuvant therapy | Tamoxifen

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0677850
UMLS CUI [3]
C0039286
patients whose tumour was estrogen receptor positive (er+).
Description

Neoplasm Estrogen receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279754
evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients for whom aromasin® treatment is contraindicated (see smpc).
Description

Medical contraindication Aromasin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0876723
metastatic breast cancer or a contra lateral tumour.
Description

Secondary malignant neoplasm of female breast | Neoplasm Contralateral

Data type

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0441988
other concomitant adjuvant endocrine therapy.
Description

Hormone Therapy Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
other concomitant antineoplastic treatment.
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
Back to the top of the page

Similar models

Eligibility Breast Neoplasms NCT01239745

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal females, defined as one from the next :
boolean
C0232970 (UMLS CUI [1])
Menopause Duration
Item
1. natural menopause ≥1 year,
boolean
C0567312 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Ovariectomy
Item
2. surgical ovariectomy,
boolean
C0029936 (UMLS CUI [1])
Amenorrhea Chemotherapy Induced
Item
3. chemotherapy-induced amenorrhoea ≥ 2 years.
boolean
C0002453 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
Operative Surgical Procedure Breast Carcinoma | Neoplasm Metastasis Absent
Item
patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Disease Free Duration | Status post Adjuvant therapy | Tamoxifen
Item
patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment.
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0039286 (UMLS CUI [3])
Neoplasm Estrogen receptor positive
Item
patients whose tumour was estrogen receptor positive (er+).
boolean
C0027651 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Aromasin
Item
patients for whom aromasin® treatment is contraindicated (see smpc).
boolean
C1301624 (UMLS CUI [1,1])
C0876723 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast | Neoplasm Contralateral
Item
metastatic breast cancer or a contra lateral tumour.
boolean
C0346993 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
Hormone Therapy Adjuvant
Item
other concomitant adjuvant endocrine therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
Cancer treatment
Item
other concomitant antineoplastic treatment.
boolean
C0920425 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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