ID

36605

Description

Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency; ODM derived from: https://clinicaltrials.gov/show/NCT02062515

Lien

https://clinicaltrials.gov/show/NCT02062515

Mots-clés

Versions (1)
  1. 26/05/2019 26/05/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

26 mai 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 Non-small Cell Lung Cancer NCT02062515

Anglais

Eligibility Non-small Cell Lung Cancer NCT02062515

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of iiib/iv stage nsclc patients who are not suitable for surgery or radiotherapy
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Patients Inappropriate Operative Surgical Procedures | Patients Inappropriate Therapeutic radiology procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1522449
ecog performance status points (ps) is 0-2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
liver function:
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
a (mild hepatic dysfunction):
Description

Liver dysfunction, mild

Type de données

boolean

Alias
UMLS CUI [1]
C3279149
a1) total bilirubin within normal limit (uln), while ast> uln;
Description

Serum bilirubin normal | Aspartate aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1]
C0428443
UMLS CUI [2]
C0151904
a2) total bilirubin within1.0-1 .5 × uln;
Description

Elevated total bilirubin

Type de données

boolean

Alias
UMLS CUI [1]
C0741494
b (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × uln
Description

Liver Dysfunction Moderate | Elevated total bilirubin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C0741494
no malabsorption or other gastrointestinal disorders effecting drug absorption
Description

Malabsorption Absent | Absence Gastrointestinal Disease Effect Drug absorption

Type de données

boolean

Alias
UMLS CUI [1,1]
C3714745
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0017178
UMLS CUI [2,3]
C1280500
UMLS CUI [2,4]
C0678745
life expectancy: more than 12 weeks.
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous usage of her/egfr inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
Description

HER2 Inhibitor | EGFR inhibitor | Target Molecule Agent | Small Molecule Agent | Monoclonal Antibody Therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1999216
UMLS CUI [2]
C1443775
UMLS CUI [3,1]
C1521840
UMLS CUI [3,2]
C0567416
UMLS CUI [3,3]
C1254351
UMLS CUI [4,1]
C1328819
UMLS CUI [4,2]
C1254351
UMLS CUI [5]
C0279694
patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
Description

Patient need for Liver Shunt | Patient need for Placement of stent | Patient need for Therapeutic radiology procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0542331
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0522776
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C1522449
patients with active hepatitis and cirrhosis.
Description

Hepatitis | Liver Cirrhosis

Type de données

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0023890
Retour au début de la page

Similar models

Eligibility Non-small Cell Lung Cancer NCT02062515

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Patients Inappropriate Operative Surgical Procedures | Patients Inappropriate Therapeutic radiology procedure
Item
histologically or cytologically confirmed diagnosis of iiib/iv stage nsclc patients who are not suitable for surgery or radiotherapy
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
ECOG performance status
Item
ecog performance status points (ps) is 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function
Item
liver function:
boolean
C0232741 (UMLS CUI [1])
Liver dysfunction, mild
Item
a (mild hepatic dysfunction):
boolean
C3279149 (UMLS CUI [1])
Serum bilirubin normal | Aspartate aminotransferase increased
Item
a1) total bilirubin within normal limit (uln), while ast> uln;
boolean
C0428443 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Elevated total bilirubin
Item
a2) total bilirubin within1.0-1 .5 × uln;
boolean
C0741494 (UMLS CUI [1])
Liver Dysfunction Moderate | Elevated total bilirubin
Item
b (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × uln
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
Malabsorption Absent | Absence Gastrointestinal Disease Effect Drug absorption
Item
no malabsorption or other gastrointestinal disorders effecting drug absorption
boolean
C3714745 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0017178 (UMLS CUI [2,2])
C1280500 (UMLS CUI [2,3])
C0678745 (UMLS CUI [2,4])
Life Expectancy
Item
life expectancy: more than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HER2 Inhibitor | EGFR inhibitor | Target Molecule Agent | Small Molecule Agent | Monoclonal Antibody Therapy
Item
previous usage of her/egfr inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
boolean
C0069515 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
C1521840 (UMLS CUI [3,1])
C0567416 (UMLS CUI [3,2])
C1254351 (UMLS CUI [3,3])
C1328819 (UMLS CUI [4,1])
C1254351 (UMLS CUI [4,2])
C0279694 (UMLS CUI [5])
Patient need for Liver Shunt | Patient need for Placement of stent | Patient need for Therapeutic radiology procedure
Item
patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
boolean
C0686904 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0542331 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0522776 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
Hepatitis | Liver Cirrhosis
Item
patients with active hepatitis and cirrhosis.
boolean
C0019158 (UMLS CUI [1])
C0023890 (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