ID

29778

Description

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

Lien

https://clinicaltrials.gov/show/NCT00712855

Mots-clés

  1. 19/04/2018 19/04/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 avril 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT00712855

Eligibility Hepatocellular Carcinoma NCT00712855

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate liver disease
Description

Liver disease Moderate

Type de données

boolean

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

Hepatitis B surface antigen positive | Hepatitis C antibody test positive

Type de données

boolean

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

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

Type de données

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
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

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

Pharmacotherapy Liver carcinoma | Investigational New Drugs

Type de données

boolean

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

Therapeutic radiology procedure

Type de données

boolean

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

Major surgery

Type de données

boolean

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

Minor Surgical Procedures

Type de données

boolean

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

Systemic steroids

Type de données

boolean

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

Hepatic Encephalopathy

Type de données

boolean

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

Gastrointestinal Hemorrhage Requirement Procedural intervention

Type de données

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
Description

Communicable Disease Requirement Hospitalization | Communicable Disease Requirement Antibiotics

Type de données

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
Description

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

Type de données

boolean

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

Cancer Other

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

boolean

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

HIV Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0019693

Similar models

Eligibility Hepatocellular Carcinoma NCT00712855

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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