ID
43415
Beschrijving
A Controlled Randomized Double-blind Multi-center Phase II Study of FOLFOX6 or FOLFIRI Combined With Sorafenib Versus Placebo in Second-line Metastatic Colorectal Carcinoma NCT00889343 ODM derived from http://clinicaltrials.gov/show/NCT00889343
Link
http://clinicaltrials.gov/show/NCT00889343
Trefwoorden
Versies (4)
- 09-12-13 09-12-13 - Martin Dugas
- 17-04-14 17-04-14 - Julian Varghese
- 29-09-15 29-09-15 - Martin Dugas
- 20-09-21 20-09-21 -
Geüploaded op
20 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Carcinoma FOLFOX6 or FOLFIRI Combined With Sorafenib NCT00889343
Eligibility Metastatic Colorectal Carcinoma FOLFOX6 or FOLFIRI Combined With Sorafenib NCT00889343
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI-1
- C0680251
Beschrijving
History of cardiac disease
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- 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
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
- SNOMED CT 2011_0131
- 422293003
- MedDRA 14.1
- 10064082
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
- SNOMED CT 2011_0131
- 67507000
- MedDRA 14.1
- 10066860
- UMLS CUI [1]
- C0559157
Beschrijving
History of HIV infection or chronic hepatitis B or C
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- 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
- SNOMED CT 2011_0131
- 61977001
- MedDRA 14.1
- 10008910
- ICD-10-CM Version 2010
- B18.1
- SNOMED CT 2011_0131
- 128302006
- MedDRA 14.1
- 10008912
- ICD-10-CM Version 2010
- B18.2
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0019693
- UMLS CUI [1,3]
- C0524909
- UMLS CUI [1,4]
- C0524910
Beschrijving
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205404
- SNOMED CT 2011_0131
- 42745003
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C1560948
- CTCAE 1105E
- MTHU114619
- UMLS CUI 2011AA
- C1560949
- CTCAE 1105E
- MTHU115603
- UMLS CUI 2011AA
- C1560950
- CTCAE 1105E
- MTHU116429
Beschrijving
Symptomatic metastatic brain or meningeal tumors
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 77879006
- MedDRA 14.1
- 10027474
- SNOMED CT 2011_0131
- 126952004
- MedDRA 14.1
- 10061019
- ICD-9-CM Version 2011
- 239.6
- UMLS CUI [1,1]
- C0036525
- UMLS CUI [1,2]
- C0006118
- UMLS CUI [1,3]
- C1334722
Beschrijving
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Datatype
boolean
Alias
- 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
- C1514873
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0038317
- SNOMED CT 2011_0131
- 116566001
- UMLS CUI 2011AA
- C0003299
- SNOMED CT 2011_0131
- 255632006
- LOINC Version 232
- MTHU006781
Beschrijving
History of organ allograft
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- LOINC Version 232
- MTHU020170
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0029216
Beschrijving
Patients with evidence or history of bleeding diathesis
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0005779
Beschrijving
Patients undergoing renal dialysis
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011946
- SNOMED CT 2011_0131
- 265764009
- MedDRA 14.1
- 10049051
Beschrijving
Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1959620
- SNOMED CT 2011_0131
- 77365006
- MedDRA 14.1
- 10052622
Beschrijving
Contraindications for the use of atropine in patients receiving FOLFIRI
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0004259
- SNOMED CT 2011_0131
- 73949004
- LOINC Version 232
- MTHU002117
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1880658
Beschrijving
Previous or concurrent cancer
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- HL7 V3 2006_05
- E
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- SNOMED CT 2011_0131
- 425231005
- SNOMED CT 2011_0131
- 261663004
- SNOMED CT 2011_0131
- 44401000
- SNOMED CT 2011_0131
- 23351008
- UMLS CUI [1,1]
- C0205420
- UMLS CUI [1,2]
- C0006826
Beschrijving
Peripheral sensory neuropathy > CTC grade 2
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0151313
- SNOMED CT 2011_0131
- 95662005
- MedDRA 14.1
- 10034620
- CTCAE 1105E
- E12768
- UMLS CUI 2011AA
- C1557260
- CTCAE 1105E
- MTHU114803
- UMLS CUI 2011AA
- C1557261
- CTCAE 1105E
- MTHU115776
- UMLS CUI 2011AA
- C1557262
- CTCAE 1105E
- MTHU116556
Beschrijving
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1856359
- UMLS CUI 2011AA
- C1258215
- SNOMED CT 2011_0131
- 81060008
- MedDRA 14.1
- 10021328
- CTCAE 1105E
- E10812
- UMLS CUI 2011AA
- C0016751
- SNOMED CT 2011_0131
- 20052008
- MedDRA 14.1
- 10019878
- ICD-10-CM Version 2010
- E74.12
- ICD-9-CM Version 2011
- 271.2
Beschrijving
Pregnant or breast-feeding patients.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
Beschrijving
No pregnancy
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 224526002
- SNOMED CT 2011_0131
- 250425007
- MedDRA 14.1
- 10036574
- SNOMED CT 2011_0131
- 224526002
- SNOMED CT 2011_0131
- 339947000
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
- SNOMED CT 2011_0131
- 268460000
- MedDRA 14.1
- 10022745
- MedDRA 14.1
- 10062577
- SNOMED CT 2011_0131
- 268464009
- SNOMED CT 2011_0131
- 47037006
- MedDRA 14.1
- 10029805
- SNOMED CT 2011_0131
- 268457007
- UMLS CUI [1]
- C0232973
Beschrijving
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0740858
- SNOMED CT 2011_0131
- 66214007
- MedDRA 14.1
- 10066169
- LOINC Version 232
- MTHU019364
- 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
- C2348568
- UMLS CUI 2011AA
- C0220825
- UMLS CUI 2011AA
- C0683954
Beschrijving
Unstable condition
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- SNOMED CT 2011_0131
- 263922001
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- SNOMED CT 2011_0131
- 45704003
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI [1]
- C0443343
Beschrijving
Patients unable to swallow oral medications.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0221470
- SNOMED CT 2011_0131
- 249486008
- MedDRA 14.1
- 10049866
- ICD-10-CM Version 2010
- R13.0
- UMLS CUI 2011AA
- C0304289
- SNOMED CT 2011_0131
- 40461009
Beschrijving
Other anticancer chemotherapy or immunotherapy past 4 weeks
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 74964007
- SNOMED CT 2011_0131
- 150415003
- SNOMED CT 2011_0131
- 146638005
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0021083
- UMLS CUI [1,3]
- C3828653
Beschrijving
Radiotherapy past 3 weeks
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 75554001
- UMLS CUI [1]
- C0034619
Beschrijving
Major surgery within 4 weeks of start of study
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0679637
Beschrijving
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0194037
- SNOMED CT 2011_0131
- 58776007
- UMLS CUI 2011AA
- C2825926
Beschrijving
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 260676000
- SNOMED CT 2011_0131
- 80572003
- LOINC Version 232
- MTHU031847
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0005525
- UMLS CUI [1,3]
- C0079459
Beschrijving
Other trial
Datatype
boolean
Alias
- SNOMED CT 2011_0131
- 52101004
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI [1]
- C2348568
Beschrijving
Prior exposure to the study drug.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0332157
- SNOMED CT 2011_0131
- 24932003
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
Beschrijving
Any St. John´s wort containing remedy
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0936242
- SNOMED CT 2011_0131
- 51621002
- UMLS CUI 2011AA
- C0332256
- SNOMED CT 2011_0131
- 42504009
- UMLS CUI 2011AA
- C0013227
Similar models
Eligibility Metastatic Colorectal Carcinoma FOLFOX6 or FOLFIRI Combined With Sorafenib NCT00889343
397669002 (SNOMED CT 2011_0131)
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113091000 (SNOMED CT 2011_0131)
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C1519815 (UMLS CUI [1,3])
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
67507000 (SNOMED CT 2011_0131)
10066860 (MedDRA 14.1)
C0559157 (UMLS CUI [1])
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
61977001 (SNOMED CT 2011_0131)
10008910 (MedDRA 14.1)
B18.1 (ICD-10-CM Version 2010)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
C0262926 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
C0524910 (UMLS CUI [1,4])
42745003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1560948 (UMLS CUI 2011AA)
MTHU114619 (CTCAE 1105E)
C1560949 (UMLS CUI 2011AA)
MTHU115603 (CTCAE 1105E)
C1560950 (UMLS CUI 2011AA)
MTHU116429 (CTCAE 1105E)
10027474 (MedDRA 14.1)
126952004 (SNOMED CT 2011_0131)
10061019 (MedDRA 14.1)
239.6 (ICD-9-CM Version 2011)
C0036525 (UMLS CUI [1,1])
C0006118 (UMLS CUI [1,2])
C1334722 (UMLS CUI [1,3])
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)
C1514873 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
MTHU020170 (LOINC Version 232)
C0262926 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
265764009 (SNOMED CT 2011_0131)
10049051 (MedDRA 14.1)
77365006 (SNOMED CT 2011_0131)
10052622 (MedDRA 14.1)
397745006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0004259 (UMLS CUI 2011AA)
73949004 (SNOMED CT 2011_0131)
MTHU002117 (LOINC Version 232)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1880658 (UMLS CUI 2011AA)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
E (HL7 V3 2006_05)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
425231005 (SNOMED CT 2011_0131)
261663004 (SNOMED CT 2011_0131)
44401000 (SNOMED CT 2011_0131)
23351008 (SNOMED CT 2011_0131)
C0205420 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
95662005 (SNOMED CT 2011_0131)
10034620 (MedDRA 14.1)
E12768 (CTCAE 1105E)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
C1258215 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10021328 (MedDRA 14.1)
E10812 (CTCAE 1105E)
C0016751 (UMLS CUI 2011AA)
20052008 (SNOMED CT 2011_0131)
10019878 (MedDRA 14.1)
E74.12 (ICD-10-CM Version 2010)
271.2 (ICD-9-CM Version 2011)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
224526002 (SNOMED CT 2011_0131)
339947000 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
10062577 (MedDRA 14.1)
268464009 (SNOMED CT 2011_0131)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
268457007 (SNOMED CT 2011_0131)
C0232973 (UMLS CUI [1])
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C0683954 (UMLS CUI 2011AA)
COND (HL7 V3 2006_05)
263922001 (SNOMED CT 2011_0131)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
45704003 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI [1])
249486008 (SNOMED CT 2011_0131)
10049866 (MedDRA 14.1)
R13.0 (ICD-10-CM Version 2010)
C0304289 (UMLS CUI 2011AA)
40461009 (SNOMED CT 2011_0131)
150415003 (SNOMED CT 2011_0131)
146638005 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI [1,1])
C0021083 (UMLS CUI [1,2])
C3828653 (UMLS CUI [1,3])
C0034619 (UMLS CUI [1])
58776007 (SNOMED CT 2011_0131)
C2825926 (UMLS CUI 2011AA)
80572003 (SNOMED CT 2011_0131)
MTHU031847 (LOINC Version 232)
C1524063 (UMLS CUI [1,1])
C0005525 (UMLS CUI [1,2])
C0079459 (UMLS CUI [1,3])
110465008 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI [1])
288556008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
51621002 (SNOMED CT 2011_0131)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)