ID
3713
Description
ODM derived from http://clinicaltrials.gov/show/NCT01246986
Link
http://clinicaltrials.gov/show/NCT01246986
Keywords
Versions (3)
- 2/22/13 2/22/13 - Martin Dugas
- 4/19/14 4/19/14 - Julian Varghese
- 9/27/21 9/27/21 -
Uploaded on
February 22, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01246986 Carcinoma
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
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
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
- C0019204
- 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
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
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
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
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
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
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
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
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
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
Description
Females who are pregnant or lactating
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
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
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
- C0021311
- 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
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Eligibility
- StudyEvent: Eligibility
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248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
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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)
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C0237399 (UMLS CUI 2011AA)
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410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
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)
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50.5 (ICD-9-CM Version 2011)
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276140008 (SNOMED CT 2011_0131)
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38112003 (SNOMED CT 2011_0131)
CL415196 (UMLS CUI 2011AA)
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C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
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)
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255603008 (SNOMED CT 2011_0131)
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78235001 (SNOMED CT 2011_0131)
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45704003 (SNOMED CT 2011_0131)