ID

20601

Description

Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00529763

Lien

https://clinicaltrials.gov/show/NCT00529763

Mots-clés

Versions (1)
  1. 06/03/2017 06/03/2017 -
Téléchargé le

6 mars 2017

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 Leukemia NCT00529763

Anglais

Eligibility Leukemia NCT00529763

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00529763
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
men and women, ages 18 years of age or older
Description

age, gender

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
subjects with chronic phase (cp) or advanced disease (ad) chronic myeloid leukemia (cml)/ph+ acute lymphoblastic leukemia (ph+ all)
Description

Chronic phase; Myeloid Leukemia, Chronic | Advanced phase; Myeloid Leukemia, Chronic | Acute lymphocytic leukemia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0457343
UMLS CUI [1,2]
C0023473
UMLS CUI [2,1]
C0205179
UMLS CUI [2,2]
C0023473
UMLS CUI [3]
C0023449
subjects resistant/intolerant to imatinib
Description

intolerance to substance; imatinib | Treatment-Resistant; imatinib

Type de données

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0935989
UMLS CUI [2,1]
C4020575
UMLS CUI [2,2]
C0935989
1. eastern cooperative oncology group (ecog) performance status (ps) score 0-2
Description

ecog

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
2. adequate hepatic function
Description

liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
3. adequate renal function
Description

renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
4. sodium, potassium, magnesium, phosphorus, calcium higher or equal than the lower limit of normal range
Description

Sodium measurement | Potassium measurement | Magnesium measurement | Phosphate measurement | Calcium measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0337443
UMLS CUI [2]
C0202194
UMLS CUI [3]
C0373675
UMLS CUI [4]
C0523826
UMLS CUI [5]
C0201925
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of child bearing potential who are not using adequate birth control
Description

Female of child bearing age | Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2]
C0700589
women who are pregnant or breastfeeding
Description

pregnancy, breast feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects eligible for stem cell transplantation
Description

subjects eligible for stem cell transplantation

Type de données

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C1548635
serious uncontrolled medical disorder or active infection
Description

serious uncontrolled medical disorder or active infection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205177
UMLS CUI [3,1]
C0439801
UMLS CUI [3,2]
C0525058
uncontrolled or significant cardiovascular disease
Description

cardiovascular disease

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
concurrent incurable malignancy other than cml
Description

concurrent incurable malignancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0175969
UMLS CUI [1,3]
C0205420
subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, dasatinib in the past
Description

imatinib | Interferon | Cytarabine | Antineoplastic Agents | hydroxyurea | dasatinib; Prior Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0935989
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0010711
UMLS CUI [4]
C0003392
UMLS CUI [5]
C0020402
UMLS CUI [6]
C1455147
UMLS CUI [7]
C1514463
history of significant bleeding unrelated to cml
Description

medical history hemorrhage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019080
Retour au début de la page

Similar models

Eligibility Leukemia NCT00529763

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00529763
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
age, gender
Item
men and women, ages 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Chronic phase; Myeloid Leukemia, Chronic | Advanced phase; Myeloid Leukemia, Chronic | Acute lymphocytic leukemia
Item
subjects with chronic phase (cp) or advanced disease (ad) chronic myeloid leukemia (cml)/ph+ acute lymphoblastic leukemia (ph+ all)
boolean
C0457343 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C0205179 (UMLS CUI [2,1])
C0023473 (UMLS CUI [2,2])
C0023449 (UMLS CUI [3])
intolerance to substance; imatinib | Treatment-Resistant; imatinib
Item
subjects resistant/intolerant to imatinib
boolean
C1744706 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C4020575 (UMLS CUI [2,1])
C0935989 (UMLS CUI [2,2])
ecog
Item
1. eastern cooperative oncology group (ecog) performance status (ps) score 0-2
boolean
C1520224 (UMLS CUI [1])
liver function
Item
2. adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
renal function
Item
3. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Sodium measurement | Potassium measurement | Magnesium measurement | Phosphate measurement | Calcium measurement
Item
4. sodium, potassium, magnesium, phosphorus, calcium higher or equal than the lower limit of normal range
boolean
C0337443 (UMLS CUI [1])
C0202194 (UMLS CUI [2])
C0373675 (UMLS CUI [3])
C0523826 (UMLS CUI [4])
C0201925 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Female of child bearing age | Contraceptive methods
Item
women of child bearing potential who are not using adequate birth control
boolean
C1960468 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
pregnancy, breast feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
subjects eligible for stem cell transplantation
Item
subjects eligible for stem cell transplantation
boolean
C1504389 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
serious uncontrolled medical disorder or active infection
Item
serious uncontrolled medical disorder or active infection
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0439801 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
cardiovascular disease
Item
uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
concurrent incurable malignancy
Item
concurrent incurable malignancy other than cml
boolean
C0006826 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
imatinib | Interferon | Cytarabine | Antineoplastic Agents | hydroxyurea | dasatinib; Prior Therapy
Item
subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, dasatinib in the past
boolean
C0935989 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0010711 (UMLS CUI [3])
C0003392 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C1455147 (UMLS CUI [6])
C1514463 (UMLS CUI [7])
medical history hemorrhage
Item
history of significant bleeding unrelated to cml
boolean
C0262926 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
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