ID

43428

Description

ODM derived from http://clinicaltrials.gov/show/NCT00688753

Link

http://clinicaltrials.gov/show/NCT00688753

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 4/16/14 4/16/14 - Julian Varghese
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility DRKS00004096 NCT00688753 Carcinoma

German English

Eligibility

1 forms  
  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

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with metastatic papillary renal cell carcinoma, type I or II
Description

Patients with metastatic papillary renal cell carcinoma, type I or II

Data type

boolean

Alias
UMLS CUI 2011AA
C0036525
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
UMLS CUI 2011AA
C1336839
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1336840
Patients with at least one measurable lesion
Description

Patients with at least one measurable lesion

Data type

boolean

Alias
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
ECOG performance status finding <= 1
Description

Patients with an ECOG Performance Status <=1

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Adequate bone marrow function
Description

Adequate bone marrow function

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
Adequate liver function
Description

Adequate liver function

Data type

boolean

Alias
UMLS CUI 2011AA
C1848676
Adequate renal function
Description

Adequate renal function

Data type

boolean

Alias
UMLS CUI 2011AA
C0232805
Adequate lipid profile
Description

Adequate lipid profile

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0023779
SNOMED CT 2011_0131
70106000
LOINC Version 232
MTHU003688
UMLS CUI 2011AA
C2003903
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients who had radiation therapy within 28 days prior to start of study.
Description

Patients who had radiation therapy within 28 days prior to start of study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Patients who have received prior systemic treatment for their metastatic RCC.
Description

Patients who have received prior systemic treatment for their metastatic RCC.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0278678
MedDRA 14.1
10050513
Patients who received prior therapy with VEGF pathway inhibitor.
Description

Patients who received prior therapy with VEGF pathway inhibitor.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1171892
SNOMED CT 2011_0131
417324009
LOINC Version 232
MTHU016264
UMLS CUI 2011AA
C1706062
UMLS CUI 2011AA
C0243077
Patients who have previously received systemic mTOR inhibitors.
Description

Patients who have previously received systemic mTOR inhibitors.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1515672
Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
Description

Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0541315
SNOMED CT 2011_0131
428698007
LOINC Version 232
MTHU026817
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0072980
SNOMED CT 2011_0131
387014003
LOINC Version 232
MTHU013897
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Patients with uncontrolled central nervous system (CNS) metastases.
Description

Patients with uncontrolled central nervous system (CNS) metastases.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0279130
SNOMED CT 2011_0131
261731003
Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
Description

Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
Patients with a known history of HIV seropositivity.
Description

Patients with a known history of HIV seropositivity.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0521143
SNOMED CT 2011_0131
4879001
Autoimmune Hepatitis
Description

Patients with autoimmune hepatitis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0241910
SNOMED CT 2011_0131
408335007
MedDRA 14.1
10003827
ICD-10-CM Version 2010
K75.4
ICD-9-CM Version 2011
571.42
Patients with an active, bleeding diathesis.
Description

Patients with an active, bleeding diathesis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
Description

Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
Description

Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1306459
SNOMED CT 2011_0131
372087000
UMLS CUI 2011AA
C1518544
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
Description

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.

Data type

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
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
Description

Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0039798
Patients unwilling to or unable to comply with the protocol.
Description

Patients unwilling to or unable to comply with the protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0525058
Back to the top of the page

Similar models

Eligibility

1 forms
  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)
Patients with metastatic papillary renal cell carcinoma, type I or II
Item
Patients with metastatic papillary renal cell carcinoma, type I or II
boolean
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C1336839 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1336840 (UMLS CUI 2011AA)
Patients with at least one measurable lesion
Item
Patients with at least one measurable lesion
boolean
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
Patients with an ECOG Performance Status <=1
Item
ECOG performance status finding <= 1
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Adequate bone marrow function
Item
Adequate bone marrow function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
Adequate liver function
Item
Adequate liver function
boolean
C1848676 (UMLS CUI 2011AA)
Adequate renal function
Item
Adequate renal function
boolean
C0232805 (UMLS CUI 2011AA)
Adequate lipid profile
Item
Adequate lipid profile
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0023779 (UMLS CUI 2011AA)
70106000 (SNOMED CT 2011_0131)
MTHU003688 (LOINC Version 232)
C2003903 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients who had radiation therapy within 28 days prior to start of study.
Item
Patients who had radiation therapy within 28 days prior to start of study.
boolean
C0034619 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (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)
C2348558 (UMLS CUI 2011AA)
Patients who have received prior systemic treatment for their metastatic RCC.
Item
Patients who have received prior systemic treatment for their metastatic RCC.
boolean
C1514756 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0278678 (UMLS CUI 2011AA)
10050513 (MedDRA 14.1)
Patients who received prior therapy with VEGF pathway inhibitor.
Item
Patients who received prior therapy with VEGF pathway inhibitor.
boolean
C1514756 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C1171892 (UMLS CUI 2011AA)
417324009 (SNOMED CT 2011_0131)
MTHU016264 (LOINC Version 232)
C1706062 (UMLS CUI 2011AA)
C0243077 (UMLS CUI 2011AA)
Patients who have previously received systemic mTOR inhibitors.
Item
Patients who have previously received systemic mTOR inhibitors.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1515672 (UMLS CUI 2011AA)
Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
Item
Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0541315 (UMLS CUI 2011AA)
428698007 (SNOMED CT 2011_0131)
MTHU026817 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Patients with uncontrolled central nervous system (CNS) metastases.
Item
Patients with uncontrolled central nervous system (CNS) metastases.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0279130 (UMLS CUI 2011AA)
261731003 (SNOMED CT 2011_0131)
Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
Item
Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
boolean
C1514756 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
Patients with a known history of HIV seropositivity.
Item
Patients with a known history of HIV seropositivity.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
Patients with autoimmune hepatitis.
Item
Autoimmune Hepatitis
boolean
C0241910 (UMLS CUI 2011AA)
408335007 (SNOMED CT 2011_0131)
10003827 (MedDRA 14.1)
K75.4 (ICD-10-CM Version 2010)
571.42 (ICD-9-CM Version 2011)
Patients with an active, bleeding diathesis.
Item
Patients with an active, bleeding diathesis.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
Item
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
Item
Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C1518544 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0699893 (UMLS CUI 2011AA)
10040810 (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)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
Item
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
Item
Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (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)
C2348558 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Patients unwilling to or unable to comply with the protocol.
Item
Patients unwilling to or unable to comply with the protocol.
boolean
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial