ID

44700

Description

ODM derived from http://clinicaltrials.gov/show/NCT01246986

Link

http://clinicaltrials.gov/show/NCT01246986

Keywords

Versions (3)
  1. 2/22/13 2/22/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT01246986 Carcinoma

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Have histological evidence of a diagnosis of HCC not amenable to curative surgery
Description

Have histological evidence of a diagnosis of HCC not amenable to curative surgery

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C2239176
MedDRA 14.1
10049010
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1704632
UMLS CUI 2011AA
C1511562
Serum alpha fetoprotein >= 1.5 Upper Limits of Normal
Description

Serum alpha fetoprotein >= 1.5 Upper Limits of Normal

Data type

boolean

Alias
UMLS CUI 2011AA
C1271652
SNOMED CT 2011_0131
391516001
UMLS CUI 2011AA
C1519815
Child-Pugh Stage A
Description

Child-Pugh Stage A

Data type

boolean

Alias
UMLS CUI 2011AA
C4050412
UMLS CUI 2011AA
C0441778
SNOMED CT 2011_0131
261618000
Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
Description

Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C1513041
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C1709926
Have given written informed consent prior to any study-specific procedures
Description

Have given written informed consent prior to any study-specific procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Have adequate hematologic, hepatic and renal function
Description

Have adequate hematologic, hepatic and renal function

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0221130
SNOMED CT 2011_0131
86084001
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
ECOG performance status finding <= 1
Description

Have a performance status of <= 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment
Description

Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1516119
SNOMED CT 2011_0131
422042001
UMLS CUI 2011AA
C1947901
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C1555471
HL7 V3 2006_05
NELG
UMLS CUI 2011AA
C1516119
SNOMED CT 2011_0131
422042001
UMLS CUI 2011AA
C0039798
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Description

Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C2347947
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
UMLS CUI 2011AA
C0525058
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Description

Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Females with childbearing potential must have had a negative serum pregnancy test <= 7 days prior to the first dose of study drug
Description

Females with childbearing potential must have had a negative serum pregnancy test <= 7 days prior to the first dose of study drug

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
Are able to swallow capsules or tablets
Description

Are able to swallow capsules or tablets

Data type

boolean

Alias
UMLS CUI 2011AA
C2712086
SNOMED CT 2011_0131
288936000
UMLS CUI 2011AA
C0006935
SNOMED CT 2011_0131
385049006
HL7 V3 2006_05
CAP
UMLS CUI 2011AA
C0039225
SNOMED CT 2011_0131
385055001
HL7 V3 2006_05
TAB
Exclusion Criteria
Description

Exclusion Criteria

Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Description

Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Data type

boolean

Alias
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0681814
UMLS CUI 2011AA
C0679426
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Known HCC with fibro-lamellar or mixed histology
Description

Known HCC with fibro-lamellar or mixed histology

Data type

boolean

Alias
UMLS CUI 2011AA
C0334287
SNOMED CT 2011_0131
253018005
UMLS CUI 2011AA
C2239176
MedDRA 14.1
10049010
UMLS CUI 2011AA
C0205430
SNOMED CT 2011_0131
26242008
UMLS CUI 2011AA
C0344441
MedDRA 14.1
10062005
LOINC Version 232
MTHU010496
Presence of clinically relevant ascitis
Description

Presence of clinically relevant ascitis

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
CL415363
History of liver transplant
Description

History of liver transplant

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0023911
SNOMED CT 2011_0131
18027006
MedDRA 14.1
10024714
ICD-9-CM Version 2011
50.5
Have received > 1 line of systemic treatment
Description

Have received > 1 line of systemic treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
CL415196
UMLS CUI 2011AA
C1515119
Have moderate or severe cardiac disease:
Description

Have moderate or severe cardiac disease:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension
Description

Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion
Description

Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
UMLS CUI 2011AA
C1704258
Have major abnormalities documented by echocardiography with Doppler. For additional details
Description

Have major abnormalities documented by echocardiography with Doppler. For additional details

Data type

boolean

Alias
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0013520
MedDRA 14.1
10053094
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
Description

Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress

Data type

boolean

Alias
UMLS CUI 2011AA
C0012655
SNOMED CT 2011_0131
76522002
UMLS CUI 2011AA
C1511795
UMLS CUI 2011AA
C0856747
SNOMED CT 2011_0131
425963007
MedDRA 14.1
10002347
UMLS CUI 2011AA
C0003483
SNOMED CT 2011_0131
15825003
LOINC Version 232
MTHU003021
UMLS CUI 2011AA
CL381816
Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study
Description

Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study

Data type

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Females who are pregnant or lactating
Description

Females who are pregnant or lactating

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years
Description

Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
Have active infection that would interfere with the study objectives or influence study compliance
Description

Have active infection that would interfere with the study objectives or influence study compliance

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0681832
UMLS CUI 2011AA
C0231347
SNOMED CT 2011_0131
45704003
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have histological evidence of a diagnosis of HCC not amenable to curative surgery
Item
Have histological evidence of a diagnosis of HCC not amenable to curative surgery
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2239176 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1704632 (UMLS CUI 2011AA)
C1511562 (UMLS CUI 2011AA)
Serum alpha fetoprotein >= 1.5 Upper Limits of Normal
Item
Serum alpha fetoprotein >= 1.5 Upper Limits of Normal
boolean
C1271652 (UMLS CUI 2011AA)
391516001 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
Child-Pugh Stage A
Item
Child-Pugh Stage A
boolean
C4050412 (UMLS CUI 2011AA)
C0441778 (UMLS CUI 2011AA)
261618000 (SNOMED CT 2011_0131)
Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
Item
Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C1513041 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C1709926 (UMLS CUI 2011AA)
Have given written informed consent prior to any study-specific procedures
Item
Have given written informed consent prior to any study-specific procedures
boolean
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Have adequate hematologic, hepatic and renal function
Item
Have adequate hematologic, hepatic and renal function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0221130 (UMLS CUI 2011AA)
86084001 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
Have a performance status of <= 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Item
ECOG performance status finding <= 1
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment
Item
Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment
boolean
C1514756 (UMLS CUI 2011AA)
C1516119 (UMLS CUI 2011AA)
422042001 (SNOMED CT 2011_0131)
C1947901 (UMLS CUI 2011AA)
C1744706 (UMLS CUI 2011AA)
C1555471 (UMLS CUI 2011AA)
NELG (HL7 V3 2006_05)
C1516119 (UMLS CUI 2011AA)
422042001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Item
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
boolean
C2347947 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0525058 (UMLS CUI 2011AA)
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Item
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Females with childbearing potential must have had a negative serum pregnancy test <= 7 days prior to the first dose of study drug
Item
Females with childbearing potential must have had a negative serum pregnancy test <= 7 days prior to the first dose of study drug
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
Are able to swallow capsules or tablets
Item
Are able to swallow capsules or tablets
boolean
C2712086 (UMLS CUI 2011AA)
288936000 (SNOMED CT 2011_0131)
C0006935 (UMLS CUI 2011AA)
385049006 (SNOMED CT 2011_0131)
CAP (HL7 V3 2006_05)
C0039225 (UMLS CUI 2011AA)
385055001 (SNOMED CT 2011_0131)
TAB (HL7 V3 2006_05)
Item Group
Exclusion Criteria
Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Item
Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
boolean
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0681814 (UMLS CUI 2011AA)
C0679426 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Known HCC with fibro-lamellar or mixed histology
Item
Known HCC with fibro-lamellar or mixed histology
boolean
C0334287 (UMLS CUI 2011AA)
253018005 (SNOMED CT 2011_0131)
C2239176 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
C0205430 (UMLS CUI 2011AA)
26242008 (SNOMED CT 2011_0131)
C0344441 (UMLS CUI 2011AA)
10062005 (MedDRA 14.1)
MTHU010496 (LOINC Version 232)
Presence of clinically relevant ascitis
Item
Presence of clinically relevant ascitis
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
CL415363 (UMLS CUI 2011AA)
History of liver transplant
Item
History of liver transplant
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
Have received > 1 line of systemic treatment
Item
Have received > 1 line of systemic treatment
boolean
C1514756 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
CL415196 (UMLS CUI 2011AA)
C1515119 (UMLS CUI 2011AA)
Have moderate or severe cardiac disease:
Item
Have moderate or severe cardiac disease:
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1881878 (UMLS CUI 2011AA)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension
Item
Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion
Item
Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C1704258 (UMLS CUI 2011AA)
Have major abnormalities documented by echocardiography with Doppler. For additional details
Item
Have major abnormalities documented by echocardiography with Doppler. For additional details
boolean
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0013520 (UMLS CUI 2011AA)
10053094 (MedDRA 14.1)
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
Item
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
boolean
C0012655 (UMLS CUI 2011AA)
76522002 (SNOMED CT 2011_0131)
C1511795 (UMLS CUI 2011AA)
C0856747 (UMLS CUI 2011AA)
425963007 (SNOMED CT 2011_0131)
10002347 (MedDRA 14.1)
C0003483 (UMLS CUI 2011AA)
15825003 (SNOMED CT 2011_0131)
MTHU003021 (LOINC Version 232)
CL381816 (UMLS CUI 2011AA)
Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study
Item
Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study
boolean
C2347662 (UMLS CUI 2011AA)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Females who are pregnant or lactating
Item
Females who are pregnant or lactating
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years
Item
Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
Have active infection that would interfere with the study objectives or influence study compliance
Item
Have active infection that would interfere with the study objectives or influence study compliance
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial