ID

43516

Description

ODM derived from http://clinicaltrials.gov/show/NCT01104584

Lien

http://clinicaltrials.gov/show/NCT01104584

Mots-clés

Versions (2)
  1. 25/07/2013 25/07/2013 - Martin Dugas
  2. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility NCT01104584 Breast Cancer

Allemand Anglais

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
Description

Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C0856599
MedDRA 14.1
10006318
UMLS CUI 2011AA
C1706086
UMLS CUI 2011AA
C0006141
SNOMED CT 2011_0131
76752008
LOINC Version 232
MTHU011382
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1515941
UMLS CUI 2011AA
C0034927
SNOMED CT 2011_0131
3457005
UMLS CUI 2011AA
C1707501
UMLS CUI 2011AA
C0262873
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0851312
SNOMED CT 2011_0131
408469009, 392090004
MedDRA 14.1
10061734
ICD-9-CM Version 2011
85
if female, a digital XRM is required if any of the following criteria is met:
Description

if female, a digital XRM is required if any of the following criteria is met:

Type de données

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0860950
MedDRA 14.1
10012992
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
age < 50 Years
Description

a. patient is younger than 50 years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
b. patient has heterogeneously or extremely dense breasts
Description

b. patient has heterogeneously or extremely dense breasts

Type de données

boolean

Alias
UMLS CUI 2011AA
C1268646
SNOMED CT 2011_0131
129718006
UMLS CUI 2011AA
C1268647
SNOMED CT 2011_0131
129719003
c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
Description

c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).

Type de données

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
if female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
Description

if female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.

Type de données

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
C0262873
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0025329
SNOMED CT 2011_0131
78456001
has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Description

has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
UMLS CUI 2011AA
C1522609
UMLS CUI 2011AA
C1441547
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
is a female patient who is pregnant or lactating
Description

is a female patient who is pregnant or lactating

Type de données

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
has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
Description

has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.

Type de données

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0262873
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0025552
SNOMED CT 2011_0131
425620007
UMLS CUI 2011AA
C0021102
SNOMED CT 2011_0131
40388003
UMLS CUI 2011AA
C0349231
SNOMED CT 2011_0131
386808001, 386810004
MedDRA 14.1
10034912
ICD-10-CM Version 2010
F40.9
ICD-9-CM Version 2011
300.20
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0016911
SNOMED CT 2011_0131
58281002
LOINC Version 232
MTHU024403
UMLS CUI 2011AA
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
C0009924
SNOMED CT 2011_0131
385420005
has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
Description

has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.

Type de données

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0009924
SNOMED CT 2011_0131
385420005
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0262873
has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
Description

has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0023976
SNOMED CT 2011_0131
9651007
MedDRA 14.1
10024803
ICD-10-CM Version 2010
I45.81
ICD-9-CM Version 2011
426.82
UMLS CUI 2011AA
C0155626
SNOMED CT 2011_0131
57054005
MedDRA 14.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
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
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
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C0751956
has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m2).
Description

has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m2).

Type de données

boolean

Alias
UMLS CUI 2011AA
C1565662
MedDRA 14.1
10050440
ICD-10-CM Version 2010
N28.9
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0019212
SNOMED CT 2011_0131
51292008
MedDRA 14.1
10019846
ICD-10-CM Version 2010
K76.7
ICD-9-CM Version 2011
572.4
UMLS CUI 2011AA
C2712230
UMLS CUI 2011AA
C0023911
SNOMED CT 2011_0131
18027006
MedDRA 14.1
10024714
ICD-9-CM Version 2011
50.5
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10038474
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
has received chemotherapy or hormonal therapy for breast cancer within 6 months.
Description

has received chemotherapy or hormonal therapy for breast cancer within 6 months.

Type de données

boolean

Alias
UMLS CUI 2011AA
C1514756
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
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
has received hormone replacement therapy within 4 weeks prior to study drug administration.
Description

has received hormone replacement therapy within 4 weeks prior to study drug administration.

Type de données

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0282402
SNOMED CT 2011_0131
266717002
MedDRA 14.1
10020388
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
Description

is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application

Type de données

boolean

Alias
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
has prior excisional biopsy or breast surgery < 6 months before enrollment and between XRM and study MRM
Description

has prior excisional biopsy or breast surgery < 6 months before enrollment and between XRM and study MRM

Type de données

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0184921
SNOMED CT 2011_0131
8889005, 277261002
MedDRA 14.1
10015612
UMLS CUI 2011AA
C0851312
SNOMED CT 2011_0131
408469009, 392090004
MedDRA 14.1
10061734
ICD-9-CM Version 2011
85
UMLS CUI 2011AA
CL426201
UMLS CUI 2011AA
C0856599
MedDRA 14.1
10006318
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0262873
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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
Item
Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0456369 (UMLS CUI 2011AA)
277025001 (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)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0856599 (UMLS CUI 2011AA)
10006318 (MedDRA 14.1)
C1706086 (UMLS CUI 2011AA)
C0006141 (UMLS CUI 2011AA)
76752008 (SNOMED CT 2011_0131)
MTHU011382 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1515941 (UMLS CUI 2011AA)
C0034927 (UMLS CUI 2011AA)
3457005 (SNOMED CT 2011_0131)
C1707501 (UMLS CUI 2011AA)
C0262873 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0851312 (UMLS CUI 2011AA)
408469009, 392090004 (SNOMED CT 2011_0131)
10061734 (MedDRA 14.1)
85 (ICD-9-CM Version 2011)
if female, a digital XRM is required if any of the following criteria is met:
Item
if female, a digital XRM is required if any of the following criteria is met:
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0860950 (UMLS CUI 2011AA)
10012992 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
a. patient is younger than 50 years
Item
age < 50 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
b. patient has heterogeneously or extremely dense breasts
Item
b. patient has heterogeneously or extremely dense breasts
boolean
C1268646 (UMLS CUI 2011AA)
129718006 (SNOMED CT 2011_0131)
C1268647 (UMLS CUI 2011AA)
129719003 (SNOMED CT 2011_0131)
c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
Item
c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
boolean
C1518422 (UMLS CUI 2011AA)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
if female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
Item
if female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0262873 (UMLS CUI 2011AA)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0025329 (UMLS CUI 2011AA)
78456001 (SNOMED CT 2011_0131)
has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Item
has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
boolean
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C1522609 (UMLS CUI 2011AA)
C1441547 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
is a female patient who is pregnant or lactating
Item
is a female patient who is 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)
has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
Item
has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0262873 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0025552 (UMLS CUI 2011AA)
425620007 (SNOMED CT 2011_0131)
C0021102 (UMLS CUI 2011AA)
40388003 (SNOMED CT 2011_0131)
C0349231 (UMLS CUI 2011AA)
386808001, 386810004 (SNOMED CT 2011_0131)
10034912 (MedDRA 14.1)
F40.9 (ICD-10-CM Version 2010)
300.20 (ICD-9-CM Version 2011)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0016911 (UMLS CUI 2011AA)
58281002 (SNOMED CT 2011_0131)
MTHU024403 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0009924 (UMLS CUI 2011AA)
385420005 (SNOMED CT 2011_0131)
has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
Item
has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
boolean
C1514756 (UMLS CUI 2011AA)
C0086960 (UMLS CUI 2011AA)
C0009924 (UMLS CUI 2011AA)
385420005 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0262873 (UMLS CUI 2011AA)
has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
Item
has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0023976 (UMLS CUI 2011AA)
9651007 (SNOMED CT 2011_0131)
10024803 (MedDRA 14.1)
I45.81 (ICD-10-CM Version 2010)
426.82 (ICD-9-CM Version 2011)
C0155626 (UMLS CUI 2011AA)
57054005 (SNOMED CT 2011_0131)
10000891 (MedDRA 14.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
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)
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)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0751956 (UMLS CUI 2011AA)
has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m2).
Item
has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m2).
boolean
C1565662 (UMLS CUI 2011AA)
10050440 (MedDRA 14.1)
N28.9 (ICD-10-CM Version 2010)
CL420107 (UMLS CUI 2011AA)
C0019212 (UMLS CUI 2011AA)
51292008 (SNOMED CT 2011_0131)
10019846 (MedDRA 14.1)
K76.7 (ICD-10-CM Version 2010)
572.4 (ICD-9-CM Version 2011)
C2712230 (UMLS CUI 2011AA)
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
has received chemotherapy or hormonal therapy for breast cancer within 6 months.
Item
has received chemotherapy or hormonal therapy for breast cancer within 6 months.
boolean
C1514756 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
has received hormone replacement therapy within 4 weeks prior to study drug administration.
Item
has received hormone replacement therapy within 4 weeks prior to study drug administration.
boolean
C1514756 (UMLS CUI 2011AA)
C0282402 (UMLS CUI 2011AA)
266717002 (SNOMED CT 2011_0131)
10020388 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
Item
is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
boolean
C0086960 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
has prior excisional biopsy or breast surgery < 6 months before enrollment and between XRM and study MRM
Item
has prior excisional biopsy or breast surgery < 6 months before enrollment and between XRM and study MRM
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0184921 (UMLS CUI 2011AA)
8889005, 277261002 (SNOMED CT 2011_0131)
10015612 (MedDRA 14.1)
C0851312 (UMLS CUI 2011AA)
408469009, 392090004 (SNOMED CT 2011_0131)
10061734 (MedDRA 14.1)
85 (ICD-9-CM Version 2011)
CL426201 (UMLS CUI 2011AA)
C0856599 (UMLS CUI 2011AA)
10006318 (MedDRA 14.1)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0262873 (UMLS CUI 2011AA)
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