ID

29778

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00712855

Nyckelord

Versioner (1)
  1. 2018-04-19 2018-04-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00712855

Engelsk

Eligibility Hepatocellular Carcinoma NCT00712855

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate liver disease
Beskrivning

Liver disease Moderate

Datatyp

boolean

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

Hepatitis B surface antigen positive | Hepatitis C antibody test positive

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Pharmacotherapy Liver carcinoma | Investigational New Drugs

Datatyp

boolean

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

Therapeutic radiology procedure

Datatyp

boolean

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

Major surgery

Datatyp

boolean

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

Minor Surgical Procedures

Datatyp

boolean

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

Systemic steroids

Datatyp

boolean

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

Hepatic Encephalopathy

Datatyp

boolean

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

Gastrointestinal Hemorrhage Requirement Procedural intervention

Datatyp

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
Beskrivning

Communicable Disease Requirement Hospitalization | Communicable Disease Requirement Antibiotics

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Cancer Other

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Hepatocellular Carcinoma NCT00712855

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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