ID

44702

Description

ODM derived from http://clinicaltrials.gov/show/NCT01250379

Link

http://clinicaltrials.gov/show/NCT01250379

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

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License

Creative Commons BY 4.0
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Eligibility NCT01250379 Breast Cancer

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
female, female gender
Description

Female patients, >/= 18 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
Histologically confirmed HER2-negative breast cancer
Description

Histologically confirmed HER2-negative breast cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
CL412283
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
Description

Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C1947901
UMLS CUI 2011AA
C1708063
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C1282471
SNOMED CT 2011_0131
314955001
UMLS CUI 2011AA
C0278488
Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
Description

Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1708063
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
ECOG performance status 0-2
Description

ECOG performance status 0-2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
At least 28 days since prior radiation therapy or surgery and recovery from treatment
Description

At least 28 days since prior radiation therapy or surgery and recovery from treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1711239
UMLS CUI 2011AA
CL414551
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C2004454
UMLS CUI 2011AA
C0039798
Exclusion Criteria
Description

Exclusion Criteria

Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
Description

Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C2363719
MedDRA 14.1
10068301
UMLS CUI 2011AA
C2267120
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
UMLS CUI 2011AA
C1708063
Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
Description

Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
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
CL411789
UMLS CUI 2011AA
C0205124
SNOMED CT 2011_0131
26283006
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
Inadequate renal function
Description

Inadequate renal function

Data type

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
Clinically relevant cardio-vascular disease
Description

Clinically relevant cardio-vascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
Known CNS disease except for treated brain metastases
Description

Known CNS disease except for treated brain metastases

Data type

boolean

Alias
UMLS CUI 2011AA
C0007682
SNOMED CT 2011_0131
23853001
MedDRA 14.1
10007943
ICD-10-CM Version 2010
G96.9
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
Description

Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0332173
SNOMED CT 2011_0131
69620002
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0070166
SNOMED CT 2011_0131
386952008
Pregnant or lactating women
Description

Pregnant or lactating women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
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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)
Female patients, >/= 18 years of age
Item
female, female gender
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
Histologically confirmed HER2-negative breast cancer
Item
Histologically confirmed HER2-negative breast cancer
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
CL412283 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
Item
Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
boolean
C1947901 (UMLS CUI 2011AA)
C1708063 (UMLS CUI 2011AA)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C1282471 (UMLS CUI 2011AA)
314955001 (SNOMED CT 2011_0131)
C0278488 (UMLS CUI 2011AA)
Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
Item
Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
boolean
C1708063 (UMLS CUI 2011AA)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
C1524031 (UMLS CUI 2011AA)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C1947911 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
ECOG performance status 0-2
Item
ECOG performance status 0-2
boolean
C1520224 (UMLS CUI 2011AA)
At least 28 days since prior radiation therapy or surgery and recovery from treatment
Item
At least 28 days since prior radiation therapy or surgery and recovery from treatment
boolean
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1711239 (UMLS CUI 2011AA)
CL414551 (UMLS CUI 2011AA)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C2004454 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
Item
Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
boolean
C2363719 (UMLS CUI 2011AA)
10068301 (MedDRA 14.1)
C2267120 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
C1708063 (UMLS CUI 2011AA)
Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
Item
Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (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)
CL411789 (UMLS CUI 2011AA)
C0205124 (UMLS CUI 2011AA)
26283006 (SNOMED CT 2011_0131)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Inadequate renal function
Item
Inadequate renal function
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
Clinically relevant cardio-vascular disease
Item
Clinically relevant cardio-vascular disease
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
Known CNS disease except for treated brain metastases
Item
Known CNS disease except for treated brain metastases
boolean
C0007682 (UMLS CUI 2011AA)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL415147 (UMLS CUI 2011AA)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
Item
Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0070166 (UMLS CUI 2011AA)
386952008 (SNOMED CT 2011_0131)
Pregnant or lactating women
Item
Pregnant or lactating women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
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