ID
4367
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00982111
Link
http://clinicaltrials.gov/show/NCT00982111
Trefwoorden
Versies (2)
- 07-12-13 07-12-13 - Martin Dugas
- 17-09-21 17-09-21 -
Geüploaded op
7 december 2013
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility NCT00982111 Non Small Cell Lung Cancer
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Has squamous non small cell lung cancer.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1182670
- UMLS CUI 2011AA
- C0007131
- SNOMED CT 2011_0131
- 254637007
- MedDRA 14.1
- 10061873
Beschrijving
Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0920425
- UMLS CUI 2011AA
- C0003250
- SNOMED CT 2011_0131
- 49616005
- UMLS CUI 2011AA
- C1519313
- UMLS CUI 2011AA
- CL421608
- UMLS CUI 2011AA
- C0034802
- SNOMED CT 2011_0131
- 86960007
- LOINC Version 232
- MTHU004296
- UMLS CUI 2011AA
- C1171892
- SNOMED CT 2011_0131
- 417324009
- LOINC Version 232
- MTHU016264
- UMLS CUI 2011AA
- C0148199
Beschrijving
Received previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514457
- UMLS CUI 2011AA
- C0205179
- SNOMED CT 2011_0131
- 86005002
- UMLS CUI 2011AA
- C0007131
- SNOMED CT 2011_0131
- 254637007
- MedDRA 14.1
- 10061873
Beschrijving
Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0679637
- UMLS CUI 2011AA
- C0949266
- 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
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0034656
Beschrijving
Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0817096
- SNOMED CT 2011_0131
- 51185008
- UMLS CUI 2011AA
- C1522449
- SNOMED CT 2011_0131
- 108290001
- MedDRA 14.1
- 10037794
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- CL421682
- UMLS CUI 2011AA
- C0238792
- MedDRA 14.1
- 10061728
Beschrijving
Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
- UMLS CUI 2011AA
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0750536
- UMLS CUI 2011AA
- C0149783
- SNOMED CT 2011_0131
- 297279009
- MedDRA 14.1
- 10062117
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0003299
- SNOMED CT 2011_0131
- 255632006
- LOINC Version 232
- MTHU006781
Beschrijving
Has superior vena cava syndrome contraindicating hydration.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0038833
- SNOMED CT 2011_0131
- 63363004
- MedDRA 14.1
- 10042569
- CTCAE 1105E
- E13819
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- CL034943
Beschrijving
Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0018802
- 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
Beschrijving
Has experienced myocardial infarction within 6 months prior to randomization.
Datatype
boolean
Alias
- 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
- C0205452
- SNOMED CT 2011_0131
- 68244004
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0034656
Beschrijving
Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0021311
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0003232
- SNOMED CT 2011_0131
- 255631004
- UMLS CUI 2011AA
- C0332257
- SNOMED CT 2011_0131
- 55919000
- UMLS CUI 2011AA
- C0151332
- SNOMED CT 2011_0131
- 427099000
- MedDRA 14.1
- 10071157
- UMLS CUI 2011AA
- C0019693
- 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
Beschrijving
Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0027765
- SNOMED CT 2011_0131
- 118940003
- MedDRA 14.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
- UMLS CUI 2011AA
- C0455498
- SNOMED CT 2011_0131
- 161464003
- 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
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
- UMLS CUI 2011AA
- C0005586
- SNOMED CT 2011_0131
- 13746004
- MedDRA 14.1
- 10057667
- LOINC Version 232
- MTHU026189
- ICD-10-CM Version 2010
- F31
- ICD-9-CM Version 2011
- 296.80
Beschrijving
Has Grade >= 2 peripheral neuropathy.
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
- C1522446
- UMLS CUI 2011AA
- C0450094
- UMLS CUI 2011AA
- C0547054
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
- UMLS CUI 2011AA
- C0205451
- SNOMED CT 2011_0131
- 34001005
Beschrijving
Has significant third space fluid retention, requiring repeated drainage.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205437
- SNOMED CT 2011_0131
- 70905002
- UMLS CUI 2011AA
- C0229984
- SNOMED CT 2011_0131
- 2969000
- UMLS CUI 2011AA
- CL427986
- UMLS CUI 2011AA
- CL025467
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0205341
- SNOMED CT 2011_0131
- 27582007
- UMLS CUI 2011AA
- C0013103
- SNOMED CT 2011_0131
- 122462000
Beschrijving
Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient's ability to complete the study or sign an informed consent document.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0809986
- UMLS CUI 2011AA
- C0449295
- SNOMED CT 2011_0131
- 246175000
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C1554962
- HL7 V3 2006_05
- C
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C2348583
Beschrijving
The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- CL414967
- UMLS CUI 2011AA
- C1705957
- UMLS CUI 2011AA
- C2352806
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
Beschrijving
Is pregnant or breastfeeding.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Beschrijving
Has a known history of drug abuse.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1299544
- SNOMED CT 2011_0131
- 371435006
Beschrijving
Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for >= 3 years.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205420
- SNOMED CT 2011_0131
- 68405009
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- 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
- CL411789
- 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
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Eligibility
- StudyEvent: Eligibility
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76498008 (SNOMED CT 2011_0131)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
CL424941 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
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MTHU004296 (LOINC Version 232)
C1171892 (UMLS CUI 2011AA)
417324009 (SNOMED CT 2011_0131)
MTHU016264 (LOINC Version 232)
C0148199 (UMLS CUI 2011AA)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
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288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
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10062117 (MedDRA 14.1)
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255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
63363004 (SNOMED CT 2011_0131)
10042569 (MedDRA 14.1)
E13819 (CTCAE 1105E)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
CL034943 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
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19032002 (SNOMED CT 2011_0131)
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42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
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55919000 (SNOMED CT 2011_0131)
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
C0019693 (UMLS CUI 2011AA)
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10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
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392521001 (SNOMED CT 2011_0131)
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118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0455498 (UMLS CUI 2011AA)
161464003 (SNOMED CT 2011_0131)
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)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0005586 (UMLS CUI 2011AA)
13746004 (SNOMED CT 2011_0131)
10057667 (MedDRA 14.1)
MTHU026189 (LOINC Version 232)
F31 (ICD-10-CM Version 2010)
296.80 (ICD-9-CM Version 2011)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C1522446 (UMLS CUI 2011AA)
C0450094 (UMLS CUI 2011AA)
C0547054 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
70905002 (SNOMED CT 2011_0131)
C0229984 (UMLS CUI 2011AA)
2969000 (SNOMED CT 2011_0131)
CL427986 (UMLS CUI 2011AA)
CL025467 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
19032002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0809986 (UMLS CUI 2011AA)
C0449295 (UMLS CUI 2011AA)
246175000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2348583 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
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C1705248 (UMLS CUI 2011AA)
CL414967 (UMLS CUI 2011AA)
C1705957 (UMLS CUI 2011AA)
C2352806 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
371435006 (SNOMED CT 2011_0131)
68405009 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (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)
CL411789 (UMLS CUI 2011AA)
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)