ID

3678

Description

ODM derived from http://clinicaltrials.gov/show/NCT01238029

Link

http://clinicaltrials.gov/show/NCT01238029

Keywords

Versions (3)
  1. 2/12/13 2/12/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

February 12, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01238029 Metastatic 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
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Able to comply with the protocol
Description

Able to comply with the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0525058
ECOG performance status 0-1
Description

ECOG performance status 0-1

Data type

boolean

Alias
UMLS CUI 2011AA
C1828078
SNOMED CT 2011_0131
425389002
UMLS CUI 2011AA
C1827388
SNOMED CT 2011_0131
422512005
Adequate contraception
Description

Adequate contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Confirmed Her2/neu-positive, adenocarcinoma of the breast
Description

Confirmed Her2/neu-positive, adenocarcinoma of the breast

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
CL412284
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0858252
MedDRA 14.1
10006173
At least one measurable lesion according to RECIST 1.1 criteria
Description

At least one measurable lesion according to RECIST 1.1 criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1709926
First or second chemotherapy after diagnosis of metastasis
Description

First or second chemotherapy after diagnosis of metastasis

Data type

boolean

Alias
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0027627
SNOMED CT 2011_0131
128462008
MedDRA 14.1
10027449
Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)
Description

Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)

Data type

boolean

Alias
UMLS CUI 2011AA
C1506770
SNOMED CT 2011_0131
425466009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1444656
SNOMED CT 2011_0131
410535002
UMLS CUI 2011AA
C0677850
MedDRA 14.1
10068969
UMLS CUI 2011AA
C0728747
SNOMED CT 2011_0131
387003001
UMLS CUI 2011AA
C1335499
No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
Description

No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0037088
SNOMED CT 2011_0131
404684003
UMLS CUI 2011AA
C0264716
SNOMED CT 2011_0131
48447003
MedDRA 14.1
10008908
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C2348558
Adequate hepatic and renal function value
Description

Adequate hepatic and renal function value

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C1522609
Adequate hematologic function values
Description

Adequate hematologic function values

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0221130
SNOMED CT 2011_0131
86084001
UMLS CUI 2011AA
C1522609
Exclusion Criteria
Description

Exclusion Criteria

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
Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
Description

Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Asymptomatic with regards to tumor illness
Description

Asymptomatic with regards to tumor illness

Data type

boolean

Alias
UMLS CUI 2011AA
C0231221
SNOMED CT 2011_0131
84387000
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Previous treatment with lapatinib, capecitabine or vinorelbine
Description

Previous treatment with lapatinib, capecitabine or vinorelbine

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1506770
SNOMED CT 2011_0131
425466009
UMLS CUI 2011AA
C0671970
SNOMED CT 2011_0131
108761006
UMLS CUI 2011AA
C0078257
SNOMED CT 2011_0131
108792008
Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
Description

Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1555447
HL7 V3 2006_05
MEDNEC
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0729502
SNOMED CT 2011_0131
312059006
UMLS CUI 2011AA
C2986607
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
Description

Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during 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
Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
Description

Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C1522564
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
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
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
History of vascular or cardiovascular disease within the past 6 months
Description

History of vascular or cardiovascular disease within the past 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0042373
SNOMED CT 2011_0131
27550009
MedDRA 14.1
10047062
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
All illnesses that result in malabsorption of oral medication or inability to take oral medication
Description

All illnesses that result in malabsorption of oral medication or inability to take oral medication

Data type

boolean

Alias
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0024523
SNOMED CT 2011_0131
155841000
ICD-10-CM Version 2010
K90.4
UMLS CUI 2011AA
CL436624
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1512806
Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
Description

Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides

Data type

boolean

Alias
UMLS CUI 2011AA
C0009429
UMLS CUI 2011AA
C0003451
SNOMED CT 2011_0131
372701006
UMLS CUI 2011AA
C1527178
UMLS CUI 2011AA
C0207628
UMLS CUI 2011AA
C0002556
SNOMED CT 2011_0131
324116004
Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
Description

Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A

Data type

boolean

Alias
UMLS CUI 2011AA
C0009429
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C1413881
Concurrent treatment with allopurinol
Description

Concurrent treatment with allopurinol

Data type

boolean

Alias
UMLS CUI 2011AA
C0009429
UMLS CUI 2011AA
C0002144
SNOMED CT 2011_0131
25246002
LOINC Version 232
MTHU024809
Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ). Patient can be included in the study if no recurrent disease has been observed for at least 5 years
Description

Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ). Patient can be included in the study if no recurrent disease has been observed for at least 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
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
Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
Description

Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0683578
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C2348568
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C0235828
MedDRA 14.1
10014291
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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)
Written informed consent
Item
Written informed consent
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Able to comply with the protocol
Item
Able to comply with the protocol
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
ECOG performance status 0-1
Item
ECOG performance status 0-1
boolean
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
Adequate contraception
Item
Adequate contraception
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Confirmed Her2/neu-positive, adenocarcinoma of the breast
Item
Confirmed Her2/neu-positive, adenocarcinoma of the breast
boolean
C0750484 (UMLS CUI 2011AA)
CL412284 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0858252 (UMLS CUI 2011AA)
10006173 (MedDRA 14.1)
At least one measurable lesion according to RECIST 1.1 criteria
Item
At least one measurable lesion according to RECIST 1.1 criteria
boolean
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709926 (UMLS CUI 2011AA)
First or second chemotherapy after diagnosis of metastasis
Item
First or second chemotherapy after diagnosis of metastasis
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10027449 (MedDRA 14.1)
Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)
Item
Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)
boolean
C1506770 (UMLS CUI 2011AA)
425466009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C0677850 (UMLS CUI 2011AA)
10068969 (MedDRA 14.1)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
Item
No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
C0264716 (UMLS CUI 2011AA)
48447003 (SNOMED CT 2011_0131)
10008908 (MedDRA 14.1)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C2348558 (UMLS CUI 2011AA)
Adequate hepatic and renal function value
Item
Adequate hepatic and renal function value
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1522609 (UMLS CUI 2011AA)
Adequate hematologic function values
Item
Adequate hematologic function values
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0221130 (UMLS CUI 2011AA)
86084001 (SNOMED CT 2011_0131)
C1522609 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
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)
Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
Item
Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Asymptomatic with regards to tumor illness
Item
Asymptomatic with regards to tumor illness
boolean
C0231221 (UMLS CUI 2011AA)
84387000 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (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)
Previous treatment with lapatinib, capecitabine or vinorelbine
Item
Previous treatment with lapatinib, capecitabine or vinorelbine
boolean
C1514463 (UMLS CUI 2011AA)
C1506770 (UMLS CUI 2011AA)
425466009 (SNOMED CT 2011_0131)
C0671970 (UMLS CUI 2011AA)
108761006 (SNOMED CT 2011_0131)
C0078257 (UMLS CUI 2011AA)
108792008 (SNOMED CT 2011_0131)
Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
Item
Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
boolean
C1555447 (UMLS CUI 2011AA)
MEDNEC (HL7 V3 2006_05)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0729502 (UMLS CUI 2011AA)
312059006 (SNOMED CT 2011_0131)
C2986607 (UMLS CUI 2011AA)
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
Item
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
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)
Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
Item
Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1522564 (UMLS CUI 2011AA)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
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)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
History of vascular or cardiovascular disease within the past 6 months
Item
History of vascular or cardiovascular disease within the past 6 months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0042373 (UMLS CUI 2011AA)
27550009 (SNOMED CT 2011_0131)
10047062 (MedDRA 14.1)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
All illnesses that result in malabsorption of oral medication or inability to take oral medication
Item
All illnesses that result in malabsorption of oral medication or inability to take oral medication
boolean
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
CL436624 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
Item
Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
boolean
C0009429 (UMLS CUI 2011AA)
C0003451 (UMLS CUI 2011AA)
372701006 (SNOMED CT 2011_0131)
C1527178 (UMLS CUI 2011AA)
C0207628 (UMLS CUI 2011AA)
C0002556 (UMLS CUI 2011AA)
324116004 (SNOMED CT 2011_0131)
Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
Item
Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
boolean
C0009429 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C1413881 (UMLS CUI 2011AA)
Concurrent treatment with allopurinol
Item
Concurrent treatment with allopurinol
boolean
C0009429 (UMLS CUI 2011AA)
C0002144 (UMLS CUI 2011AA)
25246002 (SNOMED CT 2011_0131)
MTHU024809 (LOINC Version 232)
Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ). Patient can be included in the study if no recurrent disease has been observed for at least 5 years
Item
Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ). Patient can be included in the study if no recurrent disease has been observed for at least 5 years
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
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)
Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
Item
Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0683578 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C1113679 (UMLS CUI 2011AA)
C0235828 (UMLS CUI 2011AA)
10014291 (MedDRA 14.1)
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