ID

38066

Descripción

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

Palabras clave

  1. 14/9/19 14/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01611051

Eligibility Breast Cancer NCT01611051

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
investigator diagnosis of breast cancer
Descripción

Breast Carcinoma

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
chemotherapy naïve
Descripción

Chemotherapy Absent

Tipo de datos

boolean

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

Body Weight

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

Platelet Count measurement

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Descripción

Exclusion Criteria

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

Bone Marrow Transplantation | Stem cell transplantation

Tipo de datos

boolean

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

Antibiotics for systemic use | Chemotherapy

Tipo de datos

boolean

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

Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
pregnancy, lactation
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Similar models

Eligibility Breast Cancer NCT01611051

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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