ID

38186

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.09.19 25.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. September 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02119715

Englisch

Eligibility Breast Cancer NCT02119715

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathology diagnosis of breast cancer,chemotherapy naïve
Beschreibung

Breast Carcinoma | Chemotherapy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
ecog performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
age 18 to 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
Beschreibung

Neoadjuvant Therapy Course Quantity | Adjuvant therapy Course Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
white blood cell ≥ 4.0×109/l; absolute neutrophil count ≥2.0 × 109/l; platelet count
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
≥ 100 × 109/l
Beschreibung

ID.6

Datentyp

boolean

alanine aminotransferase ≤1.5×uln; aspartate aminotransferase ≤1.5×uln; serum creatinine ≤1.5×uln
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201976
no obvious cardiac dysfunction
Beschreibung

Cardiac dysfunction Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Bone Marrow Transplantation Previous | Stem cell transplantation Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005961
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1504389
UMLS CUI [2,2]
C0205156
received systemic antibiotics treatment within 72 h of chemotherapy
Beschreibung

Antibiotics for systemic use | Time Period Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C3540704
UMLS CUI [2,1]
C1948053
UMLS CUI [2,2]
C0392920
other disease might have influence on bone marrow function
Beschreibung

Disease Influence Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0005953
UMLS CUI [1,4]
C0031843
radiation therapy within 4 weeks of randomization into this study
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
previous exposure or or allergic to pegylated rhg-csf
Beschreibung

Exposure to PEG-rhG-CSF | Allergic Reaction PEG-rhG-CSF

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C3852764
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C3852764
pregnancy, lactation
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Eligibility Breast Cancer NCT02119715

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Cardiac dysfunction Absent
Item
no obvious cardiac dysfunction
boolean
C3277906 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
Pregnancy | Breast Feeding
Item
pregnancy, lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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