ID

44509

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01540461

Nyckelord

Versioner (2)
  1. 2020-02-19 2020-02-19 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01540461

Engelsk

Eligibility Hepatocellular Carcinoma NCT01540461

1 Formulär  
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with:
Beskrivning

Study Subject Inclusion criteria

Datatyp

boolean

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

Primary Malignant Liver Neoplasm Advanced | Liver carcinoma Advanced

Datatyp

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
Beskrivning

Absence Systemic therapy Liver carcinoma Advanced

Datatyp

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))
Beskrivning

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

Datatyp

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
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with:
Beskrivning

Study Subject Exclusion Criteria

Datatyp

boolean

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

Metastatic malignant neoplasm to brain | Leptomeningeal disease

Datatyp

boolean

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

Brain function Impaired | Encephalopathy | Heart Disease

Datatyp

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)
Beskrivning

Fluid-filled abdomen | Ascites

Datatyp

boolean

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

Bleeding esophageal varices | Bleeding gastric varices

Datatyp

boolean

Alias
UMLS CUI [1]
C0155789
UMLS CUI [2]
C0267209
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Similar models

Eligibility Hepatocellular Carcinoma NCT01540461

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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