ID

16387

Beschrijving

Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00431795

Link

https://clinicaltrials.gov/show/NCT00431795

Trefwoorden

Versies (1)
  1. 14-07-16 14-07-16 -
Geüploaded op

14 juli 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00431795

Engels

Eligibility Breast Cancer NCT00431795

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-75 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function (absolute neutrophil count >1000/mm^3, platelet count>100000/mm^3, hemoglobin>9gr/mm^3)
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0019046
histologically- or cytologically- confirmed breast adenocarcinoma
Beschrijving

Breast adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0858252
no prior anthracycline-based chemotherapy as treatment of advanced breast cancer
Beschrijving

Anthracycline Antibiotics | Therapeutic procedure Advanced breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0003234
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3495917
no prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
Beschrijving

Prior Chemotherapy | Doxorubicin Adjuvant | Epirubicin Adjuvant

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C1522673
UMLS CUI [3,1]
C0014582
UMLS CUI [3,2]
C1522673
at least 4 weeks interval since prior anticancer treatment
Beschrijving

Interval Minimum Since cancer treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1524031
UMLS CUI [1,3]
C1711239
UMLS CUI [1,4]
C0920425
measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
Beschrijving

Measurable lesion Quantity | Secondary malignant neoplasm of bone | Ascites | Pleural effusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0153690
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0032227
life expectancy > 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
written informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or nursing
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
documented history of congestive heart failure (chf), serious arrhythmia, or myocardial infarction (within 6 months)
Beschrijving

Congestive heart failure | Cardiac Arrhythmia Serious | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0027051
other invasive malignancy except nonmelanoma skin cancer or acute infection.
Beschrijving

invasive cancer | Skin carcinoma | Acute infection

Datatype

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0275518
radiation of measurable disease (except brain metastases)
Beschrijving

Radiation Measurable Disease | Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0851346
UMLS CUI [1,2]
C1513041
UMLS CUI [2]
C0220650
progressive brain metastases according to clinical or radiological criteria.
Beschrijving

Metastatic malignant neoplasm to brain Progressive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205329
brain metastases without prior radiation therapy
Beschrijving

Metastatic malignant neoplasm to brain Without prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0279134
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00431795

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-75 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count >1000/mm^3, platelet count>100000/mm^3, hemoglobin>9gr/mm^3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Breast adenocarcinoma
Item
histologically- or cytologically- confirmed breast adenocarcinoma
boolean
C0858252 (UMLS CUI [1])
Anthracycline Antibiotics | Therapeutic procedure Advanced breast cancer
Item
no prior anthracycline-based chemotherapy as treatment of advanced breast cancer
boolean
C0003234 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3495917 (UMLS CUI [2,2])
Prior Chemotherapy | Doxorubicin Adjuvant | Epirubicin Adjuvant
Item
no prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
boolean
C1514457 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
Interval Minimum Since cancer treatment
Item
at least 4 weeks interval since prior anticancer treatment
boolean
C1272706 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,4])
Measurable lesion Quantity | Secondary malignant neoplasm of bone | Ascites | Pleural effusion
Item
measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0032227 (UMLS CUI [4])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Congestive heart failure | Cardiac Arrhythmia Serious | Myocardial Infarction
Item
documented history of congestive heart failure (chf), serious arrhythmia, or myocardial infarction (within 6 months)
boolean
C0018802 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
invasive cancer | Skin carcinoma | Acute infection
Item
other invasive malignancy except nonmelanoma skin cancer or acute infection.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0275518 (UMLS CUI [3])
Radiation Measurable Disease | Metastatic malignant neoplasm to brain
Item
radiation of measurable disease (except brain metastases)
boolean
C0851346 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Progressive
Item
progressive brain metastases according to clinical or radiological criteria.
boolean
C0220650 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Without prior radiation therapy
Item
brain metastases without prior radiation therapy
boolean
C0220650 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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