ID
4925
Description
ODM derived from http://clinicaltrials.gov/show/NCT00545077
Link
http://clinicaltrials.gov/show/NCT00545077
Keywords
Versions (2)
- 12/10/13 12/10/13 - Martin Dugas
- 4/14/14 4/14/14 - Julian Varghese
Uploaded on
April 14, 2014
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00545077 Breast Cancer
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0015219
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0205253
- SNOMED CT 2011_0131
- 88694003
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0677881
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
Description
Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0677984
- UMLS CUI 2011AA
- C0678222
- SNOMED CT 2011_0131
- 254838004
- MedDRA 14.1
- 10006204
- UMLS CUI 2011AA
- C1517001
- UMLS CUI 2011AA
- C0038895
- UMLS CUI 2011AA
- C1880198
- UMLS CUI 2011AA
- C1522449
- SNOMED CT 2011_0131
- 302505005
Description
Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0279025
- SNOMED CT 2011_0131
- 309542002, 169413002
- MedDRA 14.1
- 10065646
- UMLS CUI 2011AA
- C0036525
- SNOMED CT 2011_0131
- 77879006
- MedDRA 14.1
- 10027474
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0600558
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0279025
- SNOMED CT 2011_0131
- 309542002, 169413002
- MedDRA 14.1
- 10065646
- UMLS CUI 2011AA
- C1880198
- UMLS CUI 2011AA
- C0162425
- UMLS CUI 2011AA
- C0677850
- MedDRA 14.1
- 10068969
Description
Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- CL318109
- UMLS CUI 2011AA
- C1268567
- SNOMED CT 2011_0131
- 372917005
- UMLS CUI 2011AA
- CL425146
Description
History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
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
- C0677042
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C2348563
- UMLS CUI 2011AA
- C0459471
- SNOMED CT 2011_0131
- 280452008
- LOINC Version 232
- MTHU003869
- UMLS CUI 2011AA
- C1274040
- SNOMED CT 2011_0131
- 79409006
- 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
- 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
- CL415147
- UMLS CUI 2011AA
- C1880198
- UMLS CUI 2011AA
- C0332296
- SNOMED CT 2011_0131
- 37837009
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C1272706
- SNOMED CT 2011_0131
- 385673002
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Description
Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332120
- SNOMED CT 2011_0131
- 18669006
- UMLS CUI 2011AA
- C0279130
- SNOMED CT 2011_0131
- 261731003
- UMLS CUI 2011AA
- C0040405
- MedDRA 14.1
- 10011603
- UMLS CUI 2011AA
- C1269537
- SNOMED CT 2011_0131
- 258335003
- UMLS CUI 2011AA
- C0028580
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0034656
- UMLS CUI 2011AA
- C0750491
- SNOMED CT 2011_0131
- 415684004
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
Description
History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0332120
- SNOMED CT 2011_0131
- 18669006
- UMLS CUI 2011AA
- C1269563
- SNOMED CT 2011_0131
- 278199004
- UMLS CUI 2011AA
- C0677042
- UMLS CUI 2011AA
- C1554961
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- CL426127
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Description
History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0031117
- MedDRA 14.1
- 10029331
- ICD-10-CM Version 2010
- G64
- ICD-9-CM Version 2011
- 350-359.99
- UMLS CUI 2011AA
- C1140168
- UMLS CUI 2011AA
- C1516728
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
- UMLS CUI 2011AA
- C0439547
- SNOMED CT 2011_0131
- 272105005
- UMLS CUI 2011AA
- C0034656
Description
Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0679637
- UMLS CUI 2011AA
- C0184922
- SNOMED CT 2011_0131
- 119283008
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0175677
- SNOMED CT 2011_0131
- 417746004
- MedDRA 14.1
- 10022116
- ICD-10-CM Version 2010
- T14.9
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0034656
- UMLS CUI 2011AA
- CL414906
- UMLS CUI 2011AA
- C1517001
- UMLS CUI 2011AA
- C0679637
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0750729
- SNOMED CT 2011_0131
- 288524001
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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C0022877 (UMLS CUI 2011AA)
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C1708063 (UMLS CUI 2011AA)
C0701348 (UMLS CUI 2011AA)
386911004 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
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C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C1115804 (UMLS CUI 2011AA)
MTHU014522 (LOINC Version 232)
C0040539 (UMLS CUI 2011AA)
C0242939 (UMLS CUI 2011AA)
C0580352 (UMLS CUI 2011AA)
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C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
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C0332152 (UMLS CUI 2011AA)
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C0038895 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C1522449 (UMLS CUI 2011AA)
302505005 (SNOMED CT 2011_0131)
9130008 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
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10065646 (MedDRA 14.1)
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258335003 (SNOMED CT 2011_0131)
C0028580 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
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C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
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392521001 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C0677042 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
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91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
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119283008 (SNOMED CT 2011_0131)
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258706009 (SNOMED CT 2011_0131)
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288556008 (SNOMED CT 2011_0131)
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CL414906 (UMLS CUI 2011AA)
C1517001 (UMLS CUI 2011AA)
C0679637 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
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