Informações:
Falhas:
ID
38186
Descrição
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02119715
Link
https://clinicaltrials.gov/show/NCT02119715
Palavras-chave
Versões (1)
- 25/09/2019 25/09/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
25 de setembro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02119715
Eligibility Breast Cancer NCT02119715
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT02119715
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Breast Carcinoma | Chemotherapy Absent
Item
pathology diagnosis of breast cancer,chemotherapy naïve
boolean
C0678222 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Neoadjuvant Therapy Course Quantity | Adjuvant therapy Course Quantity
Item
available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
boolean
C0600558 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
white blood cell ≥ 4.0×109/l; absolute neutrophil count ≥2.0 × 109/l; platelet count
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
ID.6
Item
≥ 100 × 109/l
boolean
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
alanine aminotransferase ≤1.5×uln; aspartate aminotransferase ≤1.5×uln; serum creatinine ≤1.5×uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Cardiac dysfunction Absent
Item
no obvious cardiac dysfunction
boolean
C3277906 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Bone Marrow Transplantation Previous | Stem cell transplantation Previous
Item
prior bone marrow or stem cell transplantation
boolean
C0005961 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205156 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Antibiotics for systemic use | Time Period Chemotherapy
Item
received systemic antibiotics treatment within 72 h of chemotherapy
boolean
C3540704 (UMLS CUI [1])
C1948053 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1948053 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
Disease Influence Bone Marrow function
Item
other disease might have influence on bone marrow function
boolean
C0012634 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C4054723 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
Therapeutic radiology procedure
Item
radiation therapy within 4 weeks of randomization into this study
boolean
C1522449 (UMLS CUI [1])
Exposure to PEG-rhG-CSF | Allergic Reaction PEG-rhG-CSF
Item
previous exposure or or allergic to pegylated rhg-csf
boolean
C0332157 (UMLS CUI [1,1])
C3852764 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C3852764 (UMLS CUI [2,2])
C3852764 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C3852764 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy, lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])