ID

37888

Beschreibung

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

Stichworte

  1. 28.08.19 28.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. August 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT01156961

Eligibility Breast Cancer NCT01156961

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Adult | Age

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Hematologic function | Renal function | Liver function

Datentyp

boolean

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

Exclusion Criteria

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

Prior Chemotherapy Recurrent disease Locally | Prior Chemotherapy Neoplasm Metastasis

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

CNS metastases

Datentyp

boolean

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

Peripheral Neuropathy Pre-existing

Datentyp

boolean

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

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222

Ähnliche Modelle

Eligibility Breast Cancer NCT01156961

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video