ID
12131
Beschreibung
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
Stichworte
Versionen (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 -
Hochgeladen am
29. September 2015
DOI
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Lizenz
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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
Beschreibung
Ausschlusskriterien
Alias
- UMLS CUI-1
- C0680251
Beschreibung
History of cardiac disease
Datentyp
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
Beschreibung
History of HIV infection or chronic hepatitis B or C
Datentyp
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
Beschreibung
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0205404
- SNOMED CT 2011_0131
- 42745003
- UMLS CUI 2011AA
- C0021311
- 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
Beschreibung
Symptomatic metastatic brain or meningeal tumors
Datentyp
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
Beschreibung
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Datentyp
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
Beschreibung
History of organ allograft
Datentyp
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- LOINC Version 232
- MTHU020170
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0029216
Beschreibung
Patients with evidence or history of bleeding diathesis
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0005779
Beschreibung
Patients undergoing renal dialysis
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0917873
- SNOMED CT 2011_0131
- 265764009
- MedDRA 14.1
- 10049051
Beschreibung
Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1959620
- SNOMED CT 2011_0131
- 77365006
- MedDRA 14.1
- 10052622
Beschreibung
Contraindications for the use of atropine in patients receiving FOLFIRI
Datentyp
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
Beschreibung
Previous or concurrent cancer
Datentyp
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
Beschreibung
Peripheral sensory neuropathy > CTC grade 2
Datentyp
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
Beschreibung
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
Datentyp
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
Beschreibung
Pregnant or breast-feeding patients.
Datentyp
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
Beschreibung
No pregnancy
Datentyp
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
Beschreibung
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Datentyp
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
Beschreibung
Unstable condition
Datentyp
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
Beschreibung
Patients unable to swallow oral medications.
Datentyp
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
Beschreibung
Other anticancer chemotherapy or immunotherapy past 4 weeks
Datentyp
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
Beschreibung
Radiotherapy past 3 weeks
Datentyp
boolean
Alias
- SNOMED CT 2011_0131
- 75554001
- UMLS CUI [1]
- C0034619
Beschreibung
Major surgery within 4 weeks of start of study
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0679637
Beschreibung
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0194037
- SNOMED CT 2011_0131
- 58776007
- UMLS CUI 2011AA
- C2825926
Beschreibung
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry
Datentyp
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
Beschreibung
Other trial
Datentyp
boolean
Alias
- SNOMED CT 2011_0131
- 52101004
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI [1]
- C2348568
Beschreibung
Prior exposure to the study drug.
Datentyp
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
Beschreibung
Any St. John´s wort containing remedy
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0936242
- SNOMED CT 2011_0131
- 51621002
- UMLS CUI 2011AA
- C0332256
- SNOMED CT 2011_0131
- 42504009
- UMLS CUI 2011AA
- C0013227
Ähnliche Modelle
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)
C0021311 (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)