ID

44027

Description

G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00771433

Link

https://clinicaltrials.gov/show/NCT00771433

Keywords

Versions (2)
  1. 10/19/17 10/19/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00771433

English

Eligibility Breast Cancer NCT00771433

1 forms  
Criteria
Description

Criteria

diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:
Description

Chemotherapy Regimen Neoadjuvant | Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [2]
C0085533
six courses of epirubicin hydrochloride and docetaxel
Description

Epirubicin Hydrochloride | Docetaxel

Data type

boolean

Alias
UMLS CUI [1]
C0700582
UMLS CUI [2]
C0246415
six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (fec) 100 or 3 courses of fec 100 and 3 courses of docetaxel 100
Description

Fluorouracil | Epirubicin Hydrochloride | Cyclophosphamide | FEC | docetaxel

Data type

boolean

Alias
UMLS CUI [1]
C0016360
UMLS CUI [2]
C0700582
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0060133
UMLS CUI [5]
C0246415
must have received at least 2 chemotherapy regimens prior to study therapy
Description

Chemotherapy Regimen Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
no malignant hematological disease
Description

Malignant disease Hematologic Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0442867
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0332197
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
not pregnant or nursing
Description

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no contraindications to standard neoadjuvant or adjuvant chemotherapy
Description

Contraindication Absent Chemotherapy Neoadjuvant | Contraindication Absent Adjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C0600558
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0085533
no known hypersensitivity to g-csf or any of its components
Description

Hypersensitivity Absent G-CSF | Hypersensitivity Absent G-CSF Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0079459
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0079459
UMLS CUI [2,4]
C1705248
no patients deprived of liberty or under guardianship
Description

Exclusion Prisoners | Exclusion Patients Guardianship Related

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0033167
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0870627
UMLS CUI [2,4]
C0439849
no psychological, familial, social, or geographical reasons preventing follow-up
Description

Condition Absent Preventing Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C3274571
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.17

Data type

boolean

no concurrent participation in another experimental drug study
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Breast Cancer NCT00771433

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Chemotherapy Regimen Neoadjuvant | Chemotherapy, Adjuvant
Item
receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
Epirubicin Hydrochloride | Docetaxel
Item
six courses of epirubicin hydrochloride and docetaxel
boolean
C0700582 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
Fluorouracil | Epirubicin Hydrochloride | Cyclophosphamide | FEC | docetaxel
Item
six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (fec) 100 or 3 courses of fec 100 and 3 courses of docetaxel 100
boolean
C0016360 (UMLS CUI [1])
C0700582 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0060133 (UMLS CUI [4])
C0246415 (UMLS CUI [5])
Chemotherapy Regimen Quantity
Item
must have received at least 2 chemotherapy regimens prior to study therapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Malignant disease Hematologic Absent
Item
no malignant hematological disease
boolean
C0442867 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Contraindication Absent Chemotherapy Neoadjuvant | Contraindication Absent Adjuvant Chemotherapy
Item
no contraindications to standard neoadjuvant or adjuvant chemotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0600558 (UMLS CUI [1,4])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0085533 (UMLS CUI [2,3])
Hypersensitivity Absent G-CSF | Hypersensitivity Absent G-CSF Component
Item
no known hypersensitivity to g-csf or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0079459 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0079459 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
Exclusion Prisoners | Exclusion Patients Guardianship Related
Item
no patients deprived of liberty or under guardianship
boolean
C2828389 (UMLS CUI [1,1])
C0033167 (UMLS CUI [1,2])
C2828389 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0870627 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
Condition Absent Preventing Follow-up
Item
no psychological, familial, social, or geographical reasons preventing follow-up
boolean
C0348080 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C3274571 (UMLS CUI [1,4])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.17
Item
see disease characteristics
boolean
Study Subject Participation Status | Investigational New Drugs
Item
no concurrent participation in another experimental drug study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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