ID

37888

Beschrijving

A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX); ODM derived from: https://clinicaltrials.gov/show/NCT01156961

Link

https://clinicaltrials.gov/show/NCT01156961

Trefwoorden

Versies (1)
  1. 28-08-19 28-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01156961

Engels

Eligibility Breast Cancer NCT01156961

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
locally recurrent or metastatic her2-negative breast cancer
Beschrijving

Breast cancer recurrent Locally HER2 Negative | Secondary malignant neoplasm of female breast HER2 Negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C1517927
UMLS CUI [1,3]
C2348908
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C2348908
locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
Beschrijving

Recurrent disease Locally | Therapeutic radiology procedure Unsuccessful | Excision Curative intent Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C1517927
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C1272705
eastern cooperative oncology group (ecog) performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
prior adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of >/=12 months is required
Beschrijving

Chemotherapy, Adjuvant | Taxane Requirement Interval Disease Free | Status post Chemotherapy Completion

Datatype

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1272706
UMLS CUI [2,4]
C0012634
UMLS CUI [2,5]
C0332296
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C3665472
UMLS CUI [3,3]
C0205197
adequate haematological, renal and liver function
Beschrijving

Hematologic function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy for locally recurrent or metastatic disease
Beschrijving

Prior Chemotherapy Recurrent disease Locally | Prior Chemotherapy Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0277556
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0027627
radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of </= 30% of marrow-bearing bone)
Beschrijving

Therapeutic radiology procedure Neoplasm Metastasis | Exception Relief Metastatic bone pain | Exception Therapeutic radiology procedure Bone Marrow Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0564405
UMLS CUI [2,3]
C0877420
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0005953
UMLS CUI [3,4]
C0439165
cns metastases
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
pre-existing peripheral neuropathy
Beschrijving

Peripheral Neuropathy Pre-existing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
clinically significant cardiovascular disease
Beschrijving

Cardiovascular Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
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Similar models

Eligibility Breast Cancer NCT01156961

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast cancer recurrent Locally HER2 Negative | Secondary malignant neoplasm of female breast HER2 Negative
Item
locally recurrent or metastatic her2-negative breast cancer
boolean
C0278493 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C2348908 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Recurrent disease Locally | Therapeutic radiology procedure Unsuccessful | Excision Curative intent Unsuccessful
Item
locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
boolean
C0277556 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0728940 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Chemotherapy, Adjuvant | Taxane Requirement Interval Disease Free | Status post Chemotherapy Completion
Item
prior adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of >/=12 months is required
boolean
C0085533 (UMLS CUI [1])
C0215136 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1272706 (UMLS CUI [2,3])
C0012634 (UMLS CUI [2,4])
C0332296 (UMLS CUI [2,5])
C0231290 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Hematologic function | Renal function | Liver function
Item
adequate haematological, renal and liver function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Recurrent disease Locally | Prior Chemotherapy Neoplasm Metastasis
Item
previous chemotherapy for locally recurrent or metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Therapeutic radiology procedure Neoplasm Metastasis | Exception Relief Metastatic bone pain | Exception Therapeutic radiology procedure Bone Marrow Percentage
Item
radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of </= 30% of marrow-bearing bone)
boolean
C1522449 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0564405 (UMLS CUI [2,2])
C0877420 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0005953 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
CNS metastases
Item
cns metastases
boolean
C0686377 (UMLS CUI [1])
Peripheral Neuropathy Pre-existing
Item
pre-existing peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
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