ID
43415
Beskrivning
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
Länk
http://clinicaltrials.gov/show/NCT00889343
Nyckelord
Versioner (4)
- 2013-12-09 2013-12-09 - Martin Dugas
- 2014-04-17 2014-04-17 - Julian Varghese
- 2015-09-29 2015-09-29 - Martin Dugas
- 2021-09-20 2021-09-20 -
Uppladdad den
20 september 2021
DOI
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Licens
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
Beskrivning
Ausschlusskriterien
Alias
- UMLS CUI-1
- C0680251
Beskrivning
History of cardiac disease
Datatyp
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
Beskrivning
History of HIV infection or chronic hepatitis B or C
Datatyp
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
Beskrivning
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
Datatyp
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
Beskrivning
Symptomatic metastatic brain or meningeal tumors
Datatyp
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
Beskrivning
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Datatyp
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
Beskrivning
History of organ allograft
Datatyp
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- LOINC Version 232
- MTHU020170
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0029216
Beskrivning
Patients with evidence or history of bleeding diathesis
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0005779
Beskrivning
Patients undergoing renal dialysis
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0011946
- SNOMED CT 2011_0131
- 265764009
- MedDRA 14.1
- 10049051
Beskrivning
Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1959620
- SNOMED CT 2011_0131
- 77365006
- MedDRA 14.1
- 10052622
Beskrivning
Contraindications for the use of atropine in patients receiving FOLFIRI
Datatyp
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
Beskrivning
Previous or concurrent cancer
Datatyp
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
Beskrivning
Peripheral sensory neuropathy > CTC grade 2
Datatyp
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
Beskrivning
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
Datatyp
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
Beskrivning
Pregnant or breast-feeding patients.
Datatyp
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
Beskrivning
No pregnancy
Datatyp
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
Beskrivning
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Datatyp
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
Beskrivning
Unstable condition
Datatyp
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
Beskrivning
Patients unable to swallow oral medications.
Datatyp
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
Beskrivning
Other anticancer chemotherapy or immunotherapy past 4 weeks
Datatyp
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
Beskrivning
Radiotherapy past 3 weeks
Datatyp
boolean
Alias
- SNOMED CT 2011_0131
- 75554001
- UMLS CUI [1]
- C0034619
Beskrivning
Major surgery within 4 weeks of start of study
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0679637
Beskrivning
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0194037
- SNOMED CT 2011_0131
- 58776007
- UMLS CUI 2011AA
- C2825926
Beskrivning
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry
Datatyp
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
Beskrivning
Other trial
Datatyp
boolean
Alias
- SNOMED CT 2011_0131
- 52101004
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI [1]
- C2348568
Beskrivning
Prior exposure to the study drug.
Datatyp
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
Beskrivning
Any St. John´s wort containing remedy
Datatyp
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)
10011603 (MedDRA 14.1)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
10052358 (MedDRA 14.1)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
150415003 (SNOMED CT 2011_0131)
409406007 (SNOMED CT 2011_0131)
C1513041 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2045825 (UMLS CUI [1,3])
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)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
10052033 (MedDRA 14.1)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (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)
C1519815 (UMLS CUI 2011AA)
C0441932 (UMLS CUI 2011AA)
258322007 (SNOMED CT 2011_0131)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
10000630 (MedDRA 14.1)
182764009 (SNOMED CT 2011_0131)
10053468 (MedDRA 14.1)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C0525032 (UMLS CUI [1,1])
C0030605 (UMLS CUI [1,2])
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)