ID
4983
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00349076
Link
http://clinicaltrials.gov/show/NCT00349076
Trefwoorden
Versies (3)
- 09-12-13 09-12-13 - Martin Dugas
- 16-04-14 16-04-14 - Julian Varghese
- 20-09-21 20-09-21 -
Geüploaded op
16 april 2014
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility DRKS00003645 NCT00349076 Rectal Neoplasms
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Pregnant or breast feeding women
Datatype
boolean
Alias
- UMLS CUI 1
- C0549206
- MedDRA 1
- 10036586
- UMLS CUI 2
- C0006147
- MedDRA 2
- 10006247
Beschrijving
Fertile patients without adequate contraception during therapy
Datatype
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
Beschrijving
Past or ongoing drug abuse or alcoholic excess
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1444637
- SNOMED CT 2011_0131
- 410513005
- UMLS CUI 2011AA
- C0750536
- 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
Beschrijving
Prior chemotherapy
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514457
Beschrijving
Prior radiotherapy to the pelvis
Datatype
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
Beschrijving
Prior (within 4 weeks) or concurrent treatment with any other investigational agent
Datatype
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
Beschrijving
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Datatype
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
Beschrijving
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
Datatype
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
Beschrijving
Peripheral neuropathy > 2 (NCI CTC AE grading)
Datatype
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
Beschrijving
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
Datatype
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
Beschrijving
Chronic diarrhea (> NCI CTC AE-Grad 1)
Datatype
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
Beschrijving
Known allergy to substances containing platinum compounds
Datatype
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
Beschrijving
Concurrent use of the antiviral agent sorivudine or chemically related analogues
Datatype
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
Beschrijving
Known deficiency of dehydropyrimidindehydrogenase (DPD)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011155
- SNOMED CT 2011_0131
- 129453003
- UMLS CUI 2011AA
- C0058126
- SNOMED CT 2011_0131
- 259519002
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
67151002 (SNOMED CT 2011_0131)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0007113 (UMLS CUI 2011AA)
254582000 (SNOMED CT 2011_0131)
10038038 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C1300126 (UMLS CUI 2011AA)
371490004 (SNOMED CT 2011_0131)
C0746319 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0741847 (UMLS CUI 2011AA)
88834003 (SNOMED CT 2011_0131)
C0029473 (UMLS CUI 2011AA)
75506009 (SNOMED CT 2011_0131)
424122007 (SNOMED CT 2011_0131)
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)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C0017040 (UMLS CUI 2011AA)
60153001 (SNOMED CT 2011_0131)
MTHU001941 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0750536 (UMLS CUI 2011AA)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0560219 (UMLS CUI 2011AA)
160592001 (SNOMED CT 2011_0131)
288556008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0030797 (UMLS CUI 2011AA)
12921003 (SNOMED CT 2011_0131)
MTHU001438 (LOINC Version 232)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0009429 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
60224009 (SNOMED CT 2011_0131)
C0241888 (UMLS CUI 2011AA)
255401001 (SNOMED CT 2011_0131)
C0037468 (UMLS CUI 2011AA)
C0017447 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
C0086960 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0007682 (UMLS CUI 2011AA)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
C0497327 (UMLS CUI 2011AA)
52448006 (SNOMED CT 2011_0131)
10012267 (MedDRA 14.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0240021 (UMLS CUI 2011AA)
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
C1557255 (UMLS CUI 2011AA)
MTHU114539 (CTCAE 1105E)
C1557256 (UMLS CUI 2011AA)
MTHU115527 (CTCAE 1105E)
C1557257 (UMLS CUI 2011AA)
MTHU116371 (CTCAE 1105E)
MTHU034770 (LOINC Version 232)
C0205420 (UMLS CUI 2011AA)
68405009 (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)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (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)
236071009 (SNOMED CT 2011_0131)
10066556 (MedDRA 14.1)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0206135 (UMLS CUI 2011AA)
11996000 (SNOMED CT 2011_0131)
68405009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
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)