ID

38367

Description

Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01035229

Link

https://clinicaltrials.gov/show/NCT01035229

Keywords

Versions (2)
  1. 10/13/19 10/13/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma NCT01035229

English

Eligibility Carcinoma NCT01035229

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01035229
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced liver cancer
Description

Malignant neoplasm of liver Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0345904
UMLS CUI [1,2]
C0205179
prior systemic treatment with sorafenib for advanced hcc and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. specifically, this can be defined as:
Description

Systemic therapy Liver carcinoma Advanced | sorafenib | Disease Progression | Intolerance to Sorafenib

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205179
UMLS CUI [2]
C1516119
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1516119
documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment
Description

Disease Progression Radiology | sorafenib

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0043299
UMLS CUI [2]
C1516119
intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.
Description

intolerance to Sorafenib Dose Any | Sorafenib Relationship CTCAE Grades | Sorafenib Discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1516119
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1552551
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C1516119
UMLS CUI [3,2]
C1444662
note:
Description

Annotation

Data type

boolean

Alias
UMLS CUI [1]
C1706814
sorafenib must be the last antineoplastic treatment before randomization
Description

sorafenib | Cancer treatment Last

Data type

boolean

Alias
UMLS CUI [1]
C1516119
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1517741
prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed
Description

Local Therapy | Hormone Therapy | Tamoxifen

Data type

boolean

Alias
UMLS CUI [1]
C1517925
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0039286
one systemic chemotherapy regimen for advanced hcc is allowed before sorafenib treatment
Description

Systemic Chemotherapy Liver carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205179
ecog performance status of ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
child-pugh a
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C2347612
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active bleeding during the last 28 days
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
prior therapy with mtor inhibitors
Description

mTOR Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C2746052
prior liver or other organ transplantation which mandates systemic immunosuppression
Description

Transplantation of liver | Organ Transplantation | Therapeutic immunosuppression Systemic mandatory

Data type

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2]
C0029216
UMLS CUI [3,1]
C0021079
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C1514873
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Carcinoma NCT01035229

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01035229
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of liver Advanced
Item
advanced liver cancer
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Systemic therapy Liver carcinoma Advanced | sorafenib | Disease Progression | Intolerance to Sorafenib
Item
prior systemic treatment with sorafenib for advanced hcc and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. specifically, this can be defined as:
boolean
C1515119 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1516119 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C1516119 (UMLS CUI [4,2])
Disease Progression Radiology | sorafenib
Item
documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment
boolean
C0242656 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2])
intolerance to Sorafenib Dose Any | Sorafenib Relationship CTCAE Grades | Sorafenib Discontinuation
Item
intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.
boolean
C1744706 (UMLS CUI [1,1])
C1516119 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,4])
C1516119 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C1516119 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Annotation
Item
note:
boolean
C1706814 (UMLS CUI [1])
sorafenib | Cancer treatment Last
Item
sorafenib must be the last antineoplastic treatment before randomization
boolean
C1516119 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Local Therapy | Hormone Therapy | Tamoxifen
Item
prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed
boolean
C1517925 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
Systemic Chemotherapy Liver carcinoma Advanced
Item
one systemic chemotherapy regimen for advanced hcc is allowed before sorafenib treatment
boolean
C1883256 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh a
boolean
C2347612 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hemorrhage
Item
active bleeding during the last 28 days
boolean
C0019080 (UMLS CUI [1])
mTOR Inhibitor
Item
prior therapy with mtor inhibitors
boolean
C2746052 (UMLS CUI [1])
Transplantation of liver | Organ Transplantation | Therapeutic immunosuppression Systemic mandatory
Item
prior liver or other organ transplantation which mandates systemic immunosuppression
boolean
C0023911 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
C0021079 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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