ID

38186

Description

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

Lien

https://clinicaltrials.gov/show/NCT02119715

Mots-clés

Versions (1)
  1. 25/09/2019 25/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

25 septembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Breast Cancer NCT02119715

Anglais

Eligibility Breast Cancer NCT02119715

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Breast Carcinoma | Chemotherapy Absent

Type de données

boolean

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

ECOG performance status

Type de données

boolean

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

Age

Type de données

boolean

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

Neoadjuvant Therapy Course Quantity | Adjuvant therapy Course Quantity

Type de données

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
Description

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

Type de données

boolean

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

ID.6

Type de données

boolean

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

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

Type de données

boolean

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

Cardiac dysfunction Absent

Type de données

boolean

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

Exclusion Criteria

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

Bone Marrow Transplantation Previous | Stem cell transplantation Previous

Type de données

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
Description

Antibiotics for systemic use | Time Period Chemotherapy

Type de données

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
Description

Disease Influence Bone Marrow function

Type de données

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
Description

Therapeutic radiology procedure

Type de données

boolean

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

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

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT02119715

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial