ID
43429
Description
ODM derived from http://clinicaltrials.gov/show/NCT00349076
Link
http://clinicaltrials.gov/show/NCT00349076
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/16/14 4/16/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility DRKS00003645 NCT00349076 Rectal Neoplasms
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Pregnant or breast feeding women
Data type
boolean
Alias
- UMLS CUI 1
- C0549206
- MedDRA 1
- 10036586
- UMLS CUI 2
- C0006147
- MedDRA 2
- 10006247
Description
Fertile patients without adequate contraception during therapy
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL426012
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C0420844
- SNOMED CT 2011_0131
- 169450001
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0039798
Description
Past or ongoing drug abuse or alcoholic excess
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1444637
- SNOMED CT 2011_0131
- 410513005
- UMLS CUI 2011AA
- C0549178
- UMLS CUI 2011AA
- C0013146
- SNOMED CT 2011_0131
- 26416006
- MedDRA 14.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
- UMLS CUI 2011AA
- C0560219
- SNOMED CT 2011_0131
- 160592001
Description
Prior chemotherapy
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514457
Description
Prior radiotherapy to the pelvis
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0034619
- UMLS CUI 2011AA
- C0030797
- SNOMED CT 2011_0131
- 12921003
- LOINC Version 232
- MTHU001438
Description
Prior (within 4 weeks) or concurrent treatment with any other investigational agent
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- 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
- C0009429
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0013230
Description
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205486
- SNOMED CT 2011_0131
- 60224009
- UMLS CUI 2011AA
- C0241888
- SNOMED CT 2011_0131
- 255401001
- UMLS CUI 2011AA
- C0037468
- UMLS CUI 2011AA
- C0017447
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C1522577
- UMLS CUI 2011AA
- C0086960
Description
History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease. * active uncontrolled intercurrent infections or sepsis
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- 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
- C0443343
- SNOMED CT 2011_0131
- 263922001
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- C0007682
- SNOMED CT 2011_0131
- 23853001
- MedDRA 14.1
- 10007943
- ICD-10-CM Version 2010
- G96.9
- UMLS CUI 2011AA
- C0497327
- SNOMED CT 2011_0131
- 52448006
- MedDRA 14.1
- 10012267
- ICD-10-CM Version 2010
- F03
- ICD-9-CM Version 2011
- 290
- UMLS CUI 2011AA
- C0014544
- SNOMED CT 2011_0131
- 84757009
- MedDRA 14.1
- 10015037
- LOINC Version 232
- MTHU020586
- ICD-10-CM Version 2010
- G40.9
- ICD-9-CM Version 2011
- 345.9
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0240021
- UMLS CUI 2011AA
- C0243026
- SNOMED CT 2011_0131
- 91302008
- MedDRA 14.1
- 10040047
- ICD-9-CM Version 2011
- 995.91
Description
Peripheral neuropathy > 2 (NCI CTC AE grading)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0031117
- MedDRA 14.1
- 10029331
- ICD-10-CM Version 2010
- G64
- ICD-9-CM Version 2011
- 350-359.99
- UMLS CUI 2011AA
- C1557260
- CTCAE 1105E
- MTHU114803
- UMLS CUI 2011AA
- C1557261
- CTCAE 1105E
- MTHU115776
- UMLS CUI 2011AA
- C1557262
- CTCAE 1105E
- MTHU116556
- UMLS CUI 2011AA
- C1557255
- CTCAE 1105E
- MTHU114539
- UMLS CUI 2011AA
- C1557256
- CTCAE 1105E
- MTHU115527
- UMLS CUI 2011AA
- C1557257
- CTCAE 1105E
- MTHU116371
Description
Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- 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
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0205411
- SNOMED CT 2011_0131
- 88323005
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- 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
Description
Chronic diarrhea (> NCI CTC AE-Grad 1)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0401151
- SNOMED CT 2011_0131
- 236071009
- MedDRA 14.1
- 10066556
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Description
Known allergy to substances containing platinum compounds
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0206135
- SNOMED CT 2011_0131
- 11996000
Description
Concurrent use of the antiviral agent sorivudine or chemically related analogues
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205420
- SNOMED CT 2011_0131
- 68405009
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0003451
- SNOMED CT 2011_0131
- 372701006
- UMLS CUI 2011AA
- C0207628
- UMLS CUI 2011AA
- C0445223
- SNOMED CT 2011_0131
- 262094002
- UMLS CUI 2011AA
- C0243071
Description
Known deficiency of dehydropyrimidindehydrogenase (DPD)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0011155
- SNOMED CT 2011_0131
- 129453003
- UMLS CUI 2011AA
- C0058126
- SNOMED CT 2011_0131
- 259519002
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Eligibility
- StudyEvent: Eligibility
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359986008 (SNOMED CT 2011_0131)
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C1519815 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
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74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
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10012267 (MedDRA 14.1)
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260676000 (SNOMED CT 2011_0131)
C0003451 (UMLS CUI 2011AA)
372701006 (SNOMED CT 2011_0131)
C0207628 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C0243071 (UMLS CUI 2011AA)
129453003 (SNOMED CT 2011_0131)
C0058126 (UMLS CUI 2011AA)
259519002 (SNOMED CT 2011_0131)