ID

13286

Beschreibung

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

Stichworte

Versionen (1)
  1. 31.01.16 31.01.16 -
Hochgeladen am

31. Januar 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Anemia NCT00211133

Englisch

Eligibility Anemia NCT00211133

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Anemia NCT00211133
Inclusion Criteria
Beschreibung

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
Beschreibung

Participants

Datentyp

boolean

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

Body Weight

Datentyp

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
Beschreibung

gynaecological status

Datentyp

boolean

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

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Comorbidity

Datentyp

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
Beschreibung

dose intensification chemotherapy

Datentyp

boolean

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

Malignancy

Datentyp

boolean

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

Symtoms of breast cancer

Datentyp

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
Beschreibung

malignancy

Datentyp

boolean

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

anaemia

Datentyp

boolean

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

Coaguation status

Datentyp

boolean

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

Blood pressure

Datentyp

boolean

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

folate/ Vitamin b12 status

Datentyp

boolean

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

erythropoietin treatment

Datentyp

boolean

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

Allergy

Datentyp

boolean

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

gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Anemia NCT00211133

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Anemia NCT00211133
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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