ID

13286

Description

A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00211133

Link

https://clinicaltrials.gov/show/NCT00211133

Keywords

Versions (1)
  1. 1/31/16 1/31/16 -
Uploaded on

January 31, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Anemia NCT00211133

English

Eligibility Anemia NCT00211133

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Anemia NCT00211133
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients >= 18 years of age with confirmed diagnosis of metastatic breast cancer who are predicted to start chemotherapy for the first time
Description

Participants

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0346993
UMLS CUI [4]
C0392920
weight > = 40 kg (88 lbs)
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control and have a negative serum pregnancy test at the start of the study
Description

gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0032976
must have signed an informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant lung, heart, hormone, neurological, gastrointestinal, urinary tract or reproductive system disease
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0042075
UMLS CUI [7]
C0178829
receiving dose intensification chemotherapy for bone marrow or stem cell transplantation
Description

dose intensification chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0149710
cancer of the brain or brain/spinal cord disease
Description

Malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0153633
UMLS CUI [2]
C0153646
locally advanced or inflammatory breast cancer as the only symptom of breast cancer
Description

Symtoms of breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0278601
active second primary cancer or documented history of other cancer within the last 3 years
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C2735088
anemia from a cause other than cancer or radiotherapy/chemotherapy
Description

anaemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
history of stoke, clots in the lungs or legs or any other blood clotting disorders
Description

Coaguation status

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0151618
UMLS CUI [4]
C0005779
uncontrolled high blood pressure
Description

Blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
untreated folate or vitamin b12 deficiency
Description

folate/ Vitamin b12 status

Data type

boolean

Alias
UMLS CUI [1]
C0523631
UMLS CUI [2]
C0202252
treatment with epoetin alfa or other forms of erythropoietin within the last 4 weeks
Description

erythropoietin treatment

Data type

boolean

Alias
UMLS CUI [1]
C0376541
known hypersensitivity to epoetin alfa or any of its components
Description

Allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0357126
pregnant or breast-feeding
Description

gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Anemia NCT00211133

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Anemia NCT00211133
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Participants
Item
female patients >= 18 years of age with confirmed diagnosis of metastatic breast cancer who are predicted to start chemotherapy for the first time
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Body Weight
Item
weight > = 40 kg (88 lbs)
boolean
C0005910 (UMLS CUI [1])
gynaecological status
Item
postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control and have a negative serum pregnancy test at the start of the study
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
informed consent
Item
must have signed an informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity
Item
clinically significant lung, heart, hormone, neurological, gastrointestinal, urinary tract or reproductive system disease
boolean
C0024115 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0042075 (UMLS CUI [6])
C0178829 (UMLS CUI [7])
dose intensification chemotherapy
Item
receiving dose intensification chemotherapy for bone marrow or stem cell transplantation
boolean
C0149710 (UMLS CUI [1])
Malignancy
Item
cancer of the brain or brain/spinal cord disease
boolean
C0153633 (UMLS CUI [1])
C0153646 (UMLS CUI [2])
Symtoms of breast cancer
Item
locally advanced or inflammatory breast cancer as the only symptom of breast cancer
boolean
C3495949 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
malignancy
Item
active second primary cancer or documented history of other cancer within the last 3 years
boolean
C0751623 (UMLS CUI [1])
C2735088 (UMLS CUI [2])
anaemia
Item
anemia from a cause other than cancer or radiotherapy/chemotherapy
boolean
C0002871 (UMLS CUI [1])
Coaguation status
Item
history of stoke, clots in the lungs or legs or any other blood clotting disorders
boolean
C0038454 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0151618 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
Blood pressure
Item
uncontrolled high blood pressure
boolean
C0005823 (UMLS CUI [1])
folate/ Vitamin b12 status
Item
untreated folate or vitamin b12 deficiency
boolean
C0523631 (UMLS CUI [1])
C0202252 (UMLS CUI [2])
erythropoietin treatment
Item
treatment with epoetin alfa or other forms of erythropoietin within the last 4 weeks
boolean
C0376541 (UMLS CUI [1])
Allergy
Item
known hypersensitivity to epoetin alfa or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0357126 (UMLS CUI [1,2])
gynaecological status
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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