ID

29778

Descrição

A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00712855

Link

https://clinicaltrials.gov/show/NCT00712855

Palavras-chave

  1. 19/04/2018 19/04/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de abril de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT00712855

Eligibility Hepatocellular Carcinoma NCT00712855

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate liver disease
Descrição

Liver disease Moderate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205081
test positive for hepatitis b surface antigen or hepatitis c antibody
Descrição

Hepatitis B surface antigen positive | Hepatitis C antibody test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C1277805
locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma
Descrição

Advanced Adult Hepatocellular Carcinoma Locally | Liver carcinoma unresectable | Liver carcinoma Transplantation Unsuccessful | Metastatic hepatocellular carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1706732
UMLS CUI [1,2]
C1517927
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0040733
UMLS CUI [3,3]
C1272705
UMLS CUI [4]
C0744869
age 18 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma.
Descrição

Pharmacotherapy Liver carcinoma | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2239176
UMLS CUI [2]
C0013230
received radiation therapy within 4 weeks before randomization
Descrição

Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
major surgery within 4 weeks before randomization
Descrição

Major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
minor surgery within 2 weeks before randomization
Descrição

Minor Surgical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038904
systemic steroids within 1 week before randomization
Descrição

Systemic steroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2825233
hepatic encephalopathy, per the investigator's evaluation
Descrição

Hepatic Encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019151
history of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment
Descrição

Gastrointestinal Hemorrhage Requirement Procedural intervention

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C4035998
history of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
Descrição

Communicable Disease Requirement Hospitalization | Communicable Disease Requirement Antibiotics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019993
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
known brain or spinal cord metastases
Descrição

Metastatic malignant neoplasm to brain | Secondary malignant neoplasm of spinal cord

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0347016
history of other cancers within 5 years before enrollment
Descrição

Cancer Other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
pregnant or breast-feeding women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hiv infection
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693

Similar models

Eligibility Hepatocellular Carcinoma NCT00712855

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Liver disease Moderate
Item
moderate liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
Hepatitis B surface antigen positive | Hepatitis C antibody test positive
Item
test positive for hepatitis b surface antigen or hepatitis c antibody
boolean
C0149709 (UMLS CUI [1])
C1277805 (UMLS CUI [2])
Advanced Adult Hepatocellular Carcinoma Locally | Liver carcinoma unresectable | Liver carcinoma Transplantation Unsuccessful | Metastatic hepatocellular carcinoma
Item
locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma
boolean
C1706732 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0040733 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C0744869 (UMLS CUI [4])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmacotherapy Liver carcinoma | Investigational New Drugs
Item
received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma.
boolean
C0013216 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Therapeutic radiology procedure
Item
received radiation therapy within 4 weeks before randomization
boolean
C1522449 (UMLS CUI [1])
Major surgery
Item
major surgery within 4 weeks before randomization
boolean
C0679637 (UMLS CUI [1])
Minor Surgical Procedures
Item
minor surgery within 2 weeks before randomization
boolean
C0038904 (UMLS CUI [1])
Systemic steroids
Item
systemic steroids within 1 week before randomization
boolean
C2825233 (UMLS CUI [1])
Hepatic Encephalopathy
Item
hepatic encephalopathy, per the investigator's evaluation
boolean
C0019151 (UMLS CUI [1])
Gastrointestinal Hemorrhage Requirement Procedural intervention
Item
history of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment
boolean
C0017181 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4035998 (UMLS CUI [1,3])
Communicable Disease Requirement Hospitalization | Communicable Disease Requirement Antibiotics
Item
history of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain | Secondary malignant neoplasm of spinal cord
Item
known brain or spinal cord metastases
boolean
C0220650 (UMLS CUI [1])
C0347016 (UMLS CUI [2])
Cancer Other
Item
history of other cancers within 5 years before enrollment
boolean
C1707251 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])

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