Eligibility NCT00625898 Breast Cancer

ODM derived from http://clinicaltrials.gov/show/NCT00625898

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
Item
Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab
Item
Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0085076 (UMLS CUI 2011AA)
33496007 (SNOMED CT 2011_0131)
10006305 (MedDRA 14.1)
C0588162 (UMLS CUI 2011AA)
310630001 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C1710256 (UMLS CUI 2011AA)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0021102 (UMLS CUI 2011AA)
40388003 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1517741 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.
Item
Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL424941 (UMLS CUI 2011AA)
C0677582 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
CL068143 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1517741 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)
Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial
Item
Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial
boolean
C1515022 (UMLS CUI 2011AA)
MTHU032338 (LOINC Version 232)
C0475358 (UMLS CUI 2011AA)
258435002 (SNOMED CT 2011_0131)
C0851312 (UMLS CUI 2011AA)
408469009, 392090004 (SNOMED CT 2011_0131)
10061734 (MedDRA 14.1)
85 (ICD-9-CM Version 2011)
C0069515 (UMLS CUI 2011AA)
44368005 (SNOMED CT 2011_0131)
MTHU014669 (LOINC Version 232)
C0039593 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Signed and dated IRB/EC-approved consent
Item
Signed and dated IRB/EC-approved consent
boolean
C1561610 (UMLS CUI 2011AA)
S (HL7 V3 2006_05)
C0011008 (UMLS CUI 2011AA)
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
C1511481 (UMLS CUI 2011AA)
MTHU035862 (LOINC Version 232)
C1706842 (UMLS CUI 2011AA)
C0086911 (UMLS CUI 2011AA)
ECOG performance status <= 1
Item
ECOG performance status finding <= 1
boolean
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
Item
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0858252 (UMLS CUI 2011AA)
10006173 (MedDRA 14.1)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.
Item
The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.
boolean
CL412284 (UMLS CUI 2011AA)
CL415116 (UMLS CUI 2011AA)
C0039593 (UMLS CUI 2011AA)
C0021044 (UMLS CUI 2011AA)
117617002 (SNOMED CT 2011_0131)
10059656 (MedDRA 14.1)
C0017256 (UMLS CUI 2011AA)
12645001 (SNOMED CT 2011_0131)
C0162789 (UMLS CUI 2011AA)
426329006 (SNOMED CT 2011_0131)
10066931 (MedDRA 14.1)
C1516514 (UMLS CUI 2011AA)
C0162788 (UMLS CUI 2011AA)
123 (HL7 V3 2006_05)
C0023449 (UMLS CUI 2011AA)
91857003, 128822004 (SNOMED CT 2011_0131)
10060390 (MedDRA 14.1)
C91.0 (ICD-10-CM Version 2010)
204.0 (ICD-9-CM Version 2011)
All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm. ER negative and PgR negative. Histologic and/or nuclear grade 2 (intermediate) or 3 (high). Or Age < 35 years.
Item
All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm. ER negative and PgR negative. Histologic and/or nuclear grade 2 (intermediate) or 3 (high). Or Age < 35 years.
boolean
C0027646 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0441915 (UMLS CUI 2011AA)
258236004 (SNOMED CT 2011_0131)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C0332391 (UMLS CUI 2011AA)
53786006 (SNOMED CT 2011_0131)
C0332392 (UMLS CUI 2011AA)
80898003 (SNOMED CT 2011_0131)
C0332393 (UMLS CUI 2011AA)
90402004 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0024204 (UMLS CUI 2011AA)
59441001 (SNOMED CT 2011_0131)
MTHU015050 (LOINC Version 232)
C0332396 (UMLS CUI 2011AA)
C0332397 (UMLS CUI 2011AA)
C2732831 (UMLS CUI 2011AA)
443824009 (SNOMED CT 2011_0131)
C1711118 (UMLS CUI 2011AA)
C1711119 (UMLS CUI 2011AA)
C1711120 (UMLS CUI 2011AA)
C1711121 (UMLS CUI 2011AA)
C1711124 (UMLS CUI 2011AA)
C1711125 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0475440 (UMLS CUI 2011AA)
263605001 (SNOMED CT 2011_0131)
C0279756 (UMLS CUI 2011AA)
C0279766 (UMLS CUI 2011AA)
C0919553 (UMLS CUI 2011AA)
371469007 (SNOMED CT 2011_0131)
C1518435 (UMLS CUI 2011AA)
C1333838 (UMLS CUI 2011AA)
C1333843 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).
Item
Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).
boolean
C0024886 (UMLS CUI 2011AA)
172043006 (SNOMED CT 2011_0131)
10040700 (MedDRA 14.1)
85.41 (ICD-9-CM Version 2011)
C0917927 (UMLS CUI 2011AA)
C0851238 (UMLS CUI 2011AA)
392021009 (SNOMED CT 2011_0131)
10061733 (MedDRA 14.1)
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
Item
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
boolean
C0851238 (UMLS CUI 2011AA)
392021009 (SNOMED CT 2011_0131)
10061733 (MedDRA 14.1)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0677898 (UMLS CUI 2011AA)
C0007124 (UMLS CUI 2011AA)
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0229985 (UMLS CUI 2011AA)
82868003 (SNOMED CT 2011_0131)
C1706711 (UMLS CUI 2011AA)
C0184913 (UMLS CUI 2011AA)
65854006 (SNOMED CT 2011_0131)
C0024886 (UMLS CUI 2011AA)
172043006 (SNOMED CT 2011_0131)
10040700 (MedDRA 14.1)
85.41 (ICD-9-CM Version 2011)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0279563 (UMLS CUI 2011AA)
109888004 (SNOMED CT 2011_0131)
10024744 (MedDRA 14.1)
D05.0 (ICD-10-CM Version 2010)
For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
Item
For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
boolean
C0024881 (UMLS CUI 2011AA)
10026878 (MedDRA 14.1)
85.4 (ICD-9-CM Version 2011)
C0229985 (UMLS CUI 2011AA)
82868003 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0439806 (UMLS CUI 2011AA)
255344003 (SNOMED CT 2011_0131)
C0242596 (UMLS CUI 2011AA)
C0205288 (UMLS CUI 2011AA)
84496004 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0229985 (UMLS CUI 2011AA)
82868003 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive. Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b. Or Axillary lymphadenectomy without SN isolation procedure.
Item
Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive. Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b. Or Axillary lymphadenectomy without SN isolation procedure.
boolean
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C2700391 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0449927 (UMLS CUI 2011AA)
260918007 (SNOMED CT 2011_0131)
C2363825 (UMLS CUI 2011AA)
10068478 (MedDRA 14.1)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C0677944 (UMLS CUI 2011AA)
330469005 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C2363825 (UMLS CUI 2011AA)
10068478 (MedDRA 14.1)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0332396 (UMLS CUI 2011AA)
C2732831 (UMLS CUI 2011AA)
443824009 (SNOMED CT 2011_0131)
C1711119 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0193867 (UMLS CUI 2011AA)
234262008 (SNOMED CT 2011_0131)
10068477 (MedDRA 14.1)
40.23 (ICD-9-CM Version 2011)
CL411789 (UMLS CUI 2011AA)
C0677944 (UMLS CUI 2011AA)
330469005 (SNOMED CT 2011_0131)
C0204727 (UMLS CUI 2011AA)
40174006 (SNOMED CT 2011_0131)
99.84 (ICD-9-CM Version 2011)
The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
Item
The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
boolean
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0039798 (UMLS CUI 2011AA)
C0027646 (UMLS CUI 2011AA)
254292007 (SNOMED CT 2011_0131)
LP78422-0 (LOINC Version 232)
C0034656 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
Item
Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
boolean
C1521863 (UMLS CUI 2011AA)
C0002778 (UMLS CUI 2011AA)
272389005 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0279756 (UMLS CUI 2011AA)
C0034833 (UMLS CUI 2011AA)
61078009 (SNOMED CT 2011_0131)
MTHU002145 (LOINC Version 232)
C0002778 (UMLS CUI 2011AA)
272389005 (SNOMED CT 2011_0131)
C1882330 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be >= 1200/mm3. Platelet count must be >= 100,000/mm3. And Hemoglobin must be >= 10 g/dL.
Item
The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be >= 1200/mm3. Platelet count must be >= 100,000/mm3. And Hemoglobin must be >= 10 g/dL.
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0005771 (UMLS CUI 2011AA)
88308000 (SNOMED CT 2011_0131)
10064196 (MedDRA 14.1)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL414621 (UMLS CUI 2011AA)
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: total bilirubin must be <= upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin
Item
and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab
boolean
CL414621 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0311468 (UMLS CUI 2011AA)
26165005 (SNOMED CT 2011_0131)
10005364 (MedDRA 14.1)
E12096 (CTCAE 1105E)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
C2348205 (UMLS CUI 2011AA)
C0039082 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0439834 (UMLS CUI 2011AA)
255361000 (SNOMED CT 2011_0131)
C1160466 (UMLS CUI 2011AA)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.
Item
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0920364 (UMLS CUI 2011AA)
C0040405 (UMLS CUI 2011AA)
77477000 (SNOMED CT 2011_0131)
10010234 (MedDRA 14.1)
0002 (HL7 V3 2006_05)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0032743 (UMLS CUI 2011AA)
82918005 (SNOMED CT 2011_0131)
10036220 (MedDRA 14.1)
0007 (HL7 V3 2006_05)
CL381767 (UMLS CUI 2011AA)
C0441633 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0445092 (UMLS CUI 2011AA)
261985008 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1514873 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Patients with alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.
Item
Patients with alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.
boolean
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0203668 (UMLS CUI 2011AA)
41747008 (SNOMED CT 2011_0131)
10006009 (MedDRA 14.1)
92.14 (ICD-9-CM Version 2011)
C0032743 (UMLS CUI 2011AA)
82918005 (SNOMED CT 2011_0131)
10036220 (MedDRA 14.1)
0007 (HL7 V3 2006_05)
CL381767 (UMLS CUI 2011AA)
C0441633 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0445092 (UMLS CUI 2011AA)
261985008 (SNOMED CT 2011_0131)
The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be <= ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.
Item
The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be <= ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.
boolean
CL414621 (UMLS CUI 2011AA)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be < 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is >= 2+, determine the UPC ratio, which must be < 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.
Item
A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be < 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is >= 2+, determine the UPC ratio, which must be < 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.
boolean
LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).
Item
LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0851587 (UMLS CUI 2011AA)
10007574 (MedDRA 14.1)
C1547538 (UMLS CUI 2011AA)
MTHU020558 (LOINC Version 232)
C1518030 (UMLS CUI 2011AA)
The ECG (performed within 3 months prior to randomization) must not have demonstrated any of the following conditions: ventricular arrhythmias except for benign premature ventricular contractions
Item
supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
boolean
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL414352 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C1554961 (UMLS CUI 2011AA)
C0205183 (UMLS CUI 2011AA)
30807003 (SNOMED CT 2011_0131)
C0151636 (UMLS CUI 2011AA)
17338001 (SNOMED CT 2011_0131)
10047289 (MedDRA 14.1)
MTHU024512 (LOINC Version 232)
I49.3 (ICD-10-CM Version 2010)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Inflammatory breast cancer.
Item
Inflammatory Breast Carcinoma, Mastitis carcinomatosa
boolean
C0278601 (UMLS CUI 2011AA)
254840009 (SNOMED CT 2011_0131)
10021980 (MedDRA 14.1)
Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)
Item
Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0205483 (UMLS CUI 2011AA)
5526005 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0027627 (UMLS CUI 2011AA)
10027478 (MedDRA 14.1)
C1531652 (UMLS CUI 2011AA)
413815006 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0011923 (UMLS CUI 2011AA)
363679005 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).
Item
Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).
boolean
C0439580 (UMLS CUI 2011AA)
255237009 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
C0853879 (UMLS CUI 2011AA)
10006190 (MedDRA 14.1)
C0439580 (UMLS CUI 2011AA)
255237009 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
C0007124 (UMLS CUI 2011AA)
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
C0279563 (UMLS CUI 2011AA)
109888004 (SNOMED CT 2011_0131)
10024744 (MedDRA 14.1)
D05.0 (ICD-10-CM Version 2010)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)
Item
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0853879 (UMLS CUI 2011AA)
10006190 (MedDRA 14.1)
C1554079 (UMLS CUI 2011AA)
I (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0007124 (UMLS CUI 2011AA)
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0279563 (UMLS CUI 2011AA)
109888004 (SNOMED CT 2011_0131)
10024744 (MedDRA 14.1)
D05.0 (ICD-10-CM Version 2010)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
Item
History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
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)
C0154061 (UMLS CUI 2011AA)
92568009 (SNOMED CT 2011_0131)
10063523 (MedDRA 14.1)
D01.0 (ICD-10-CM Version 2010)
230.3 (ICD-9-CM Version 2011)
C0346040 (UMLS CUI 2011AA)
77986002 (SNOMED CT 2011_0131)
10027148 (MedDRA 14.1)
D03 (ICD-10-CM Version 2010)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
Item
Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
boolean
C1514463 (UMLS CUI 2011AA)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0215136 (UMLS CUI 2011AA)
C0079083 (UMLS CUI 2011AA)
386905002 (SNOMED CT 2011_0131)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)
C0796392 (UMLS CUI 2011AA)
409406007 (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)
RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.
Item
RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.
boolean
C0034619 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
CL421608 (UMLS CUI 2011AA)
C1521801 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)
Item
Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)
boolean
C0549178 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0244404 (UMLS CUI 2011AA)
109029006 (SNOMED CT 2011_0131)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
C0732611 (UMLS CUI 2011AA)
415515000 (SNOMED CT 2011_0131)
C0593802 (UMLS CUI 2011AA)
413575009 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0750557 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.
Item
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.
boolean
C0036884 (UMLS CUI 2011AA)
312263009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0729511 (UMLS CUI 2011AA)
43171004 (SNOMED CT 2011_0131)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication. Ventricular arrhythmias except for benign premature ventricular contractions. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication. Conduction abnormality requiring a pacemaker. Valvular disease with documented compromise in cardiac function. And symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function. History of documented CHF. And documented cardiomyopathy.
Item
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication. Ventricular arrhythmias except for benign premature ventricular contractions. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication. Conduction abnormality requiring a pacemaker. Valvular disease with documented compromise in cardiac function. And symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function. History of documented CHF. And documented cardiomyopathy.
boolean
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2707252 (UMLS CUI 2011AA)
MTHU031865 (LOINC Version 232)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C2707252 (UMLS CUI 2011AA)
MTHU031865 (LOINC Version 232)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C1874267 (UMLS CUI 2011AA)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205183 (UMLS CUI 2011AA)
30807003 (SNOMED CT 2011_0131)
C0151636 (UMLS CUI 2011AA)
17338001 (SNOMED CT 2011_0131)
10047289 (MedDRA 14.1)
MTHU024512 (LOINC Version 232)
I49.3 (ICD-10-CM Version 2010)
C0428974 (UMLS CUI 2011AA)
72654001 (SNOMED CT 2011_0131)
10003130 (MedDRA 14.1)
C0264893 (UMLS CUI 2011AA)
71792006 (SNOMED CT 2011_0131)
10029458 (MedDRA 14.1)
I49.8 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1842820 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0232166 (UMLS CUI 2011AA)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0031046 (UMLS CUI 2011AA)
3238004 (SNOMED CT 2011_0131)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)
CL421546 (UMLS CUI 2011AA)
392521001 (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)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1707297 (UMLS CUI 2011AA)
C0205322 (UMLS CUI 2011AA)
C0205147 (UMLS CUI 2011AA)
410673009 (SNOMED CT 2011_0131)
MTHU009053 (LOINC Version 232)
C0504053 (UMLS CUI 2011AA)
C1704258 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
C0080310 (UMLS CUI 2011AA)
250907009 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
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)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
Item
Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C0005823 (UMLS CUI 2011AA)
75367002 (SNOMED CT 2011_0131)
MTHU008342 (LOINC Version 232)
C1516048 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0497247 (UMLS CUI 2011AA)
24184005 (SNOMED CT 2011_0131)
10005750 (MedDRA 14.1)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C1704686 (UMLS CUI 2011AA)
C0456081 (UMLS CUI 2011AA)
410617001 (SNOMED CT 2011_0131)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C2003888 (UMLS CUI 2011AA)
C0005823 (UMLS CUI 2011AA)
75367002 (SNOMED CT 2011_0131)
MTHU008342 (LOINC Version 232)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL425202 (UMLS CUI 2011AA)
History of hypertensive crisis or hypertensive encephalopathy.
Item
History of hypertensive crisis or hypertensive encephalopathy.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020546 (UMLS CUI 2011AA)
50490005 (SNOMED CT 2011_0131)
10020802 (MedDRA 14.1)
C0151620 (UMLS CUI 2011AA)
50490005 (SNOMED CT 2011_0131)
10020803 (MedDRA 14.1)
I67.4 (ICD-10-CM Version 2010)
437.2 (ICD-9-CM Version 2011)
History of TIA or CVA.
Item
History of TIA or CVA.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
History of any arterial thrombotic event within 12 months before randomization.
Item
History of any arterial thrombotic event within 12 months before randomization.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0151942 (UMLS CUI 2011AA)
65198009 (SNOMED CT 2011_0131)
10003178 (MedDRA 14.1)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Symptomatic peripheral vascular disease
Item
Symptomatic peripheral vascular disease
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0085096 (UMLS CUI 2011AA)
400047006 (SNOMED CT 2011_0131)
10034636 (MedDRA 14.1)
MTHU020791 (LOINC Version 232)
I73.9 (ICD-10-CM Version 2010)
443.9 (ICD-9-CM Version 2011)
Intrinsic lung disease resulting in dyspnea
Item
Intrinsic lung disease resulting in dyspnea
boolean
C0205102 (UMLS CUI 2011AA)
260521003 (SNOMED CT 2011_0131)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0013404 (UMLS CUI 2011AA)
139201002 (SNOMED CT 2011_0131)
10013968 (MedDRA 14.1)
MTHU020850 (LOINC Version 232)
R06.0 (ICD-10-CM Version 2010)
786.05 (ICD-9-CM Version 2011)
E13368 (CTCAE 1105E)
Unstable diabetes mellitus
Item
Brittle diabetes
boolean
C0342302 (UMLS CUI 2011AA)
11530004 (SNOMED CT 2011_0131)
10006372 (MedDRA 14.1)
Active infection or chronic infection requiring chronic suppressive antibiotics.
Item
Active infection or chronic infection requiring chronic suppressive antibiotics.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205367 (UMLS CUI 2011AA)
244840000 (SNOMED CT 2011_0131)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.
Item
Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0025323 (UMLS CUI 2011AA)
386692008 (SNOMED CT 2011_0131)
10027313 (MedDRA 14.1)
N92.0 (ICD-10-CM Version 2010)
E13132 (CTCAE 1105E)
C0279752 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Non-healing wound, skin ulcers, or incompletely healed bone fracture.
Item
Non-healing wound, skin ulcers, or incompletely healed bone fracture.
boolean
C0750433 (UMLS CUI 2011AA)
125192008 (SNOMED CT 2011_0131)
C0748826 (UMLS CUI 2011AA)
L97 (ICD-10-CM Version 2010)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0205249 (UMLS CUI 2011AA)
90910008 (SNOMED CT 2011_0131)
C0016658 (UMLS CUI 2011AA)
125605004 (SNOMED CT 2011_0131)
10017076 (MedDRA 14.1)
T14.8 (ICD-10-CM Version 2010)
800-829.99 (ICD-9-CM Version 2011)
E11703 (CTCAE 1105E)
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.
Item
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.
boolean
C0679637 (UMLS CUI 2011AA)
C0184922 (UMLS CUI 2011AA)
119283008 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.
Item
Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.
boolean
C0679106 (UMLS CUI 2011AA)
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.
Item
Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.
boolean
C0030920 (UMLS CUI 2011AA)
13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
Item
History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0151664 (UMLS CUI 2011AA)
51875005 (SNOMED CT 2011_0131)
10018001 (MedDRA 14.1)
C1879311 (UMLS CUI 2011AA)
CL031631 (UMLS CUI 2011AA)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
Known bleeding diathesis or coagulopathy.
Item
Known bleeding diathesis or coagulopathy.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
Requirement for therapeutic doses of coumadin or equivalent.
Item
Requirement for therapeutic doses of coumadin or equivalent.
boolean
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C1564394 (UMLS CUI 2011AA)
CL415123 (UMLS CUI 2011AA)
Sensory/motor neuropathy >= grade 2, as defined by the NCI CTCAE v3.0.
Item
Sensory/motor neuropathy >= grade 2, as defined by the NCI CTCAE v3.0.
boolean
C0151313 (UMLS CUI 2011AA)
95662005 (SNOMED CT 2011_0131)
10034620 (MedDRA 14.1)
E12768 (CTCAE 1105E)
C1557259 (UMLS CUI 2011AA)
MTHU113783 (CTCAE 1105E)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
C0235025 (UMLS CUI 2011AA)
95663000 (SNOMED CT 2011_0131)
10034580 (MedDRA 14.1)
E12762 (CTCAE 1105E)
C1557254 (UMLS CUI 2011AA)
MTHU113523 (CTCAE 1105E)
C1557255 (UMLS CUI 2011AA)
MTHU114539 (CTCAE 1105E)
C1557256 (UMLS CUI 2011AA)
MTHU115527 (CTCAE 1105E)
C1557257 (UMLS CUI 2011AA)
MTHU116371 (CTCAE 1105E)
Conditions that would prohibit administration of corticosteroids.
Item
Conditions that would prohibit administration of corticosteroids.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0683610 (UMLS CUI 2011AA)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
Item
Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2348070 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0025815 (UMLS CUI 2011AA)
116593003 (SNOMED CT 2011_0131)
MTHU004699 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
C0586794 (UMLS CUI 2011AA)
170660006 (SNOMED CT 2011_0131)
History of hypersensitivity reaction to drugs formulated with polysorbate 80.
Item
History of hypersensitivity reaction to drugs formulated with polysorbate 80.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1705957 (UMLS CUI 2011AA)
C0032601 (UMLS CUI 2011AA)
255899003 (SNOMED CT 2011_0131)
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)
Item
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C2348558 (UMLS CUI 2011AA)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C2825407 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0021622 (UMLS CUI 2011AA)
C2828392 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Item
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
boolean
C1518371 (UMLS CUI 2011AA)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2700409 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Item
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0085281 (UMLS CUI 2011AA)
32709003 (SNOMED CT 2011_0131)
10001125 (MedDRA 14.1)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Use of any investigational product within 4 weeks prior to enrollment in the study.
Item
Use of any investigational product within 4 weeks prior to enrollment in the study.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)

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