ID

44509

Description

Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC); ODM derived from: https://clinicaltrials.gov/show/NCT01540461

Link

https://clinicaltrials.gov/show/NCT01540461

Keywords

Versions (2)
  1. 2/19/20 2/19/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatocellular Carcinoma NCT01540461

English

Eligibility Hepatocellular Carcinoma NCT01540461

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with:
Description

Study Subject Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1512693
confirmed advanced primary liver cancer (hepatocellular carcinoma: hcc)
Description

Primary Malignant Liver Neoplasm Advanced | Liver carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0024620
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205179
not having received prior systemic treatment for advanced hcc
Description

Absence Systemic therapy Liver carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C2239176
UMLS CUI [1,4]
C0205179
normal or moderately impaired liver function (child-pugh class a or b (cp total score of ≤ 7))
Description

Liver function Child-Pugh Classification | Liver Dysfunction Moderate Child-Pugh Classification | Child-Pugh - Total Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C4050412
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C4050412
UMLS CUI [3]
C4055253
eastern cooperative oncology group (ecog) performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with:
Description

Study Subject Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0680251
brain metastasis or evidence of leptomeningeal disease
Description

Metastatic malignant neoplasm to brain | Leptomeningeal disease

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0751297
history of impaired brain function (encephalopathy) or active heart disease
Description

Brain function Impaired | Encephalopathy | Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0678908
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0085584
UMLS CUI [3]
C0018799
unmanageable fluid in the abdomen (ascites)
Description

Fluid-filled abdomen | Ascites

Data type

boolean

Alias
UMLS CUI [1]
C0685931
UMLS CUI [2]
C0003962
bleeding esophageal or gastric varices within 2 months prior to inclusion
Description

Bleeding esophageal varices | Bleeding gastric varices

Data type

boolean

Alias
UMLS CUI [1]
C0155789
UMLS CUI [2]
C0267209
Back to the top of the page

Similar models

Eligibility Hepatocellular Carcinoma NCT01540461

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Study Subject Inclusion criteria
Item
subjects with:
boolean
C0681850 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Primary Malignant Liver Neoplasm Advanced | Liver carcinoma Advanced
Item
confirmed advanced primary liver cancer (hepatocellular carcinoma: hcc)
boolean
C0024620 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Absence Systemic therapy Liver carcinoma Advanced
Item
not having received prior systemic treatment for advanced hcc
boolean
C0332197 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
Liver function Child-Pugh Classification | Liver Dysfunction Moderate Child-Pugh Classification | Child-Pugh - Total Score
Item
normal or moderately impaired liver function (child-pugh class a or b (cp total score of ≤ 7))
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C4050412 (UMLS CUI [2,3])
C4055253 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Exclusion Criteria
Item
subjects with:
boolean
C0681850 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Leptomeningeal disease
Item
brain metastasis or evidence of leptomeningeal disease
boolean
C0220650 (UMLS CUI [1])
C0751297 (UMLS CUI [2])
Brain function Impaired | Encephalopathy | Heart Disease
Item
history of impaired brain function (encephalopathy) or active heart disease
boolean
C0678908 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0085584 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
Fluid-filled abdomen | Ascites
Item
unmanageable fluid in the abdomen (ascites)
boolean
C0685931 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
Bleeding esophageal varices | Bleeding gastric varices
Item
bleeding esophageal or gastric varices within 2 months prior to inclusion
boolean
C0155789 (UMLS CUI [1])
C0267209 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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