ID

14831

Description

ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00046514

Lien

https://clinicaltrials.gov/show/NCT00046514

Mots-clés

  1. 01/05/2016 01/05/2016 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

1 mai 2016

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.

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 Neoplasms NCT00046514

Eligibility Breast Neoplasms NCT00046514

Criteria
Description

Criteria

if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
Description

ID.1

Type de données

boolean

Alias
UMLS CUI [1]
C0015780
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0015895
UMLS CUI [5]
C0700589
eighteen years of age or older
Description

ID.2

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky perfomance status of 70% or 0-2 swog performance status
Description

ID.3

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
Description

ID.4

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
measurable disease
Description

ID.5

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
suitable candidate for treatment with paclitaxel
Description

ID.6

Type de données

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C0332149
previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
Description

ID.7

Type de données

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C1514463
if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
Description

ID.8

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
Description

ID.9

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0201976
patient has an expected survival of at least 12 weeks
Description

ID.10

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
patient or his/her representative has signed an informed consent statement
Description

ID.11

Type de données

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Breast Neoplasms NCT00046514

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
ID.1
Item
if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
boolean
C0015780 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015895 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
ID.2
Item
eighteen years of age or older
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
karnofsky perfomance status of 70% or 0-2 swog performance status
boolean
C0206065 (UMLS CUI [1])
ID.4
Item
no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ID.5
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
ID.6
Item
suitable candidate for treatment with paclitaxel
boolean
C0144576 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
ID.7
Item
previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
boolean
C0144576 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
ID.8
Item
if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
ID.9
Item
if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
ID.10
Item
patient has an expected survival of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ID.11
Item
patient or his/her representative has signed an informed consent statement
boolean
C0021430 (UMLS CUI [1])

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

Les champs marqués d’un * sont obligatoires.

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