ID
44665
Description
ODM derived from http://clinicaltrials.gov/show/NCT01204710
Link
http://clinicaltrials.gov/show/NCT01204710
Keywords
Versions (3)
- 12/7/13 12/7/13 - Martin Dugas
- 4/19/14 4/19/14 - Julian Varghese
- 9/27/21 9/27/21 -
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility DRKS00003665 NCT01204710 Prostate Cancer
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205420
- SNOMED CT 2011_0131
- 68405009
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0205411
- SNOMED CT 2011_0131
- 88323005
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0699893
- MedDRA 14.1
- 10040810
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0007099
- SNOMED CT 2011_0131
- 109355002
- MedDRA 14.1
- 10061450
- ICD-10-CM Version 2010
- D09.9
- ICD-9-CM Version 2011
- 234.9
Description
The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0677881
- UMLS CUI 2011AA
- C0027627
- MedDRA 14.1
- 10027478
Description
prior therapy with mitoxantrone for advanced prostate cancer
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0026259
- SNOMED CT 2011_0131
- 386913001
- UMLS CUI 2011AA
- C0205179
- SNOMED CT 2011_0131
- 86005002
- UMLS CUI 2011AA
- C0600139
- SNOMED CT 2011_0131
- 254900004
- MedDRA 14.1
- 10036921
Description
The patient has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is >= 10% below the lower limit of normal institutional range
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- 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
- C2243117
- UMLS CUI 2011AA
- C0521317
- SNOMED CT 2011_0131
- 404221001
- MedDRA 14.1
- 10028211
- UMLS CUI 2011AA
- C0428772
- SNOMED CT 2011_0131
- 250908004
- MedDRA 14.1
- 10069170
- UMLS CUI 2011AA
- C1518030
Description
history of prior treatment with other agents that directly inhibit PDGF or platelet-derived growth factor receptors
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1254351
- UMLS CUI 2011AA
- C0021469
- SNOMED CT 2011_0131
- 61511001
- UMLS CUI 2011AA
- C0032200
- SNOMED CT 2011_0131
- 10987005
- UMLS CUI 2011AA
- C0071253
Description
known allergy to any of the treatment components: IMC 3G3, mitoxantrone, and/or prednisone
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- C2703171
- UMLS CUI 2011AA
- C0026259
- SNOMED CT 2011_0131
- 386913001
- UMLS CUI 2011AA
- C0032952
- SNOMED CT 2011_0131
- 116602009
- LOINC Version 232
- MTHU003245
Description
radiotherapy within 21 days prior to first dose of IMC-3G3
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0034619
- UMLS CUI 2011AA
- C0205449
- SNOMED CT 2011_0131
- 421291004
- 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
- C0205435
- SNOMED CT 2011_0131
- 255216001
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C2703171
Description
any investigational therapy within 30 days of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0949266
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0034656
Description
is receiving corticosteroids at a dose > 5 mg prednisone orally (PO) 2 times per day (BID) or equivalent
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0520151
- UMLS CUI 2011AA
- C0585361
- SNOMED CT 2011_0131
- 229799001
- HL7 V3 2006_05
- BID
- UMLS CUI 2011AA
- CL415123
Description
received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0281385
- SNOMED CT 2011_0131
- 7770004
- UMLS CUI 2011AA
- C0361302
- SNOMED CT 2011_0131
- 353644005
- UMLS CUI 2011AA
- C1828331
- SNOMED CT 2011_0131
- 423578007
- UMLS CUI 2011AA
- C0677942
- SNOMED CT 2011_0131
- 419804008
- UMLS CUI 2011AA
- C0203608
- SNOMED CT 2011_0131
- 399315003
- UMLS CUI 2011AA
- C0005953
- SNOMED CT 2011_0131
- 14016003
- LOINC Version 232
- MTHU016536
- UMLS CUI 2011AA
- C0277785
- SNOMED CT 2011_0131
- 386585008
- UMLS CUI 2011AA
- C0205169
- SNOMED CT 2011_0131
- 556001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0151825
- SNOMED CT 2011_0131
- 12584003
- MedDRA 14.1
- 10006002
- LOINC Version 232
- MTHU020858
- CTCAE 1105E
- E12392
Description
has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- 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
- 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
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0019080
- SNOMED CT 2011_0131
- 50960005
- MedDRA 14.1
- 10055798
- ICD-10-CM Version 2010
- R58
- ICD-9-CM Version 2011
- 459.0
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
Description
known or suspected brain or leptomeningeal metastases
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
- UMLS CUI 2011AA
- CL411846
- MedDRA 14.1
- 10051696
Description
known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019693
- SNOMED CT 2011_0131
- 86406008
- MedDRA 14.1
- 10020161
- LOINC Version 232
- MTHU020829
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
- UMLS CUI 2011AA
- C0877121
- MedDRA 14.1
- 10061624
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