ID

38066

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01611051

Nyckelord

  1. 2019-09-14 2019-09-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 september 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01611051

Eligibility Breast Cancer NCT01611051

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
investigator diagnosis of breast cancer
Beskrivning

Breast Carcinoma

Datatyp

boolean

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

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
chemotherapy naïve
Beskrivning

Chemotherapy Absent

Datatyp

boolean

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

Body Weight

Datatyp

boolean

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

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

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

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

Datatyp

boolean

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

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Bone Marrow Transplantation | Stem cell transplantation

Datatyp

boolean

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

Antibiotics for systemic use | Chemotherapy

Datatyp

boolean

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

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
pregnancy, lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Similar models

Eligibility Breast Cancer NCT01611051

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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