ID

38066

Description

A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01611051

Link

https://clinicaltrials.gov/show/NCT01611051

Keywords

  1. 9/14/19 9/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 14, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01611051

Eligibility Breast Cancer NCT01611051

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
investigator diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
age 18 to 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
chemotherapy naïve
Description

Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
body weight ≥ 45kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
hemoglobin ≥ 90g/l; white blood cell ≥ 4.0×109/l; absolute neutrophil count ≥1.5 ×
Description

Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
109/l; platelet count ≥ 100 × 109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
alanine transarninase ≤1.5×uln; aspartate aminotransferase ≤1.5×uln; serum creatinine
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201976
≤1.5×uln; total bilirubin ≤1.5×uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior bone marrow or stem cell transplantation
Description

Bone Marrow Transplantation | Stem cell transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1504389
received systemic antibiotics treatment within 72 h of chemotherapy
Description

Antibiotics for systemic use | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3540704
UMLS CUI [2]
C0392920
radiation therapy within 4 weeks of randomization into this study
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
pregnancy, lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Breast Cancer NCT01611051

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
investigator diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Age
Item
age 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Absent
Item
chemotherapy naïve
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Body Weight
Item
body weight ≥ 45kg
boolean
C0005910 (UMLS CUI [1])
Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count
Item
hemoglobin ≥ 90g/l; white blood cell ≥ 4.0×109/l; absolute neutrophil count ≥1.5 ×
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
Platelet Count measurement
Item
109/l; platelet count ≥ 100 × 109/l
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
alanine transarninase ≤1.5×uln; aspartate aminotransferase ≤1.5×uln; serum creatinine
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Serum total bilirubin measurement
Item
≤1.5×uln; total bilirubin ≤1.5×uln
boolean
C1278039 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bone Marrow Transplantation | Stem cell transplantation
Item
prior bone marrow or stem cell transplantation
boolean
C0005961 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
Antibiotics for systemic use | Chemotherapy
Item
received systemic antibiotics treatment within 72 h of chemotherapy
boolean
C3540704 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Therapeutic radiology procedure
Item
radiation therapy within 4 weeks of randomization into this study
boolean
C1522449 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy, lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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