ID
5078
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT01085136
Link
http://clinicaltrials.gov/show/NCT01085136
Trefwoorden
Versies (3)
- 06-12-13 06-12-13 - Martin Dugas
- 17-04-14 17-04-14 - Julian Varghese
- 27-09-21 27-09-21 -
Geüploaded op
17 april 2014
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility NCT01085136 Carcinoma, Non-Small-Cell Lung
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0279025
- SNOMED CT 2011_0131
- 309542002, 169413002
- MedDRA 14.1
- 10065646
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0065879
- SNOMED CT 2011_0131
- 90357001
- LOINC Version 232
- MTHU018761
- UMLS CUI 2011AA
- C0038317
- SNOMED CT 2011_0131
- 116566001
- UMLS CUI 2011AA
- C0021083
- SNOMED CT 2011_0131
- 146638005
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C1268567
- SNOMED CT 2011_0131
- 372917005
- UMLS CUI 2011AA
- C1882440
Beschrijving
Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0003299
- SNOMED CT 2011_0131
- 255632006
- LOINC Version 232
- MTHU006781
- UMLS CUI 2011AA
- CL428853
- MedDRA 14.1
- 10070973
Beschrijving
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205178
- SNOMED CT 2011_0131
- 272118002
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
- UMLS CUI 2011AA
- C0011991
- SNOMED CT 2011_0131
- 62315008
- MedDRA 14.1
- 10012735
- LOINC Version 232
- MTHU013347
- ICD-10-CM Version 2010
- R19.7
- ICD-9-CM Version 2011
- 787.91
- CTCAE 1105E
- E10572
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
- UMLS CUI 2011AA
- C0024523
- SNOMED CT 2011_0131
- 155841000
- ICD-10-CM Version 2010
- K90.4
- UMLS CUI 2011AA
- C1559310
- CTCAE 1105E
- MTHU114261
- UMLS CUI 2011AA
- C1559311
- CTCAE 1105E
- MTHU115273
- UMLS CUI 2011AA
- C1559312
- CTCAE 1105E
- MTHU116177
Beschrijving
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2826244
- UMLS CUI 2011AA
- C0221423
- SNOMED CT 2011_0131
- 39104002
- MedDRA 14.1
- 10040658
- ICD-10-CM Version 2010
- R69
- UMLS CUI 2011AA
- C0460002
- SNOMED CT 2011_0131
- 91689009
- UMLS CUI 2011AA
- C0277785
- SNOMED CT 2011_0131
- 386585008
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C1113679
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0013175
- SNOMED CT 2011_0131
- 185922005
Beschrijving
Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- 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
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0699893
- MedDRA 14.1
- 10040810
- 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
Radiotherapy within the past 2 weeks prior to treatment with the trial drug
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0034619
- UMLS CUI 2011AA
- C0205448
- SNOMED CT 2011_0131
- 19338005
- 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
- C0039798
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
Beschrijving
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- 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
- UMLS CUI 2011AA
- C0002962
- SNOMED CT 2011_0131
- 194828000
- MedDRA 14.1
- 10002383
- ICD-10-CM Version 2010
- I20
- ICD-9-CM Version 2011
- 413
- 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
- C0003811
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
- UMLS CUI 2011AA
- C1319795
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
Beschrijving
Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0428772
- SNOMED CT 2011_0131
- 250908004
- MedDRA 14.1
- 10069170
- UMLS CUI 2011AA
- C0017200
- UMLS CUI 2011AA
- C0521317
- SNOMED CT 2011_0131
- 404221001
- MedDRA 14.1
- 10028211
- UMLS CUI 2011AA
- C2243117
Beschrijving
QTc interval at or > 0.47 second
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0489625
- LOINC Version 232
- MTHU024527
Beschrijving
Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0282564
- SNOMED CT 2011_0131
- 372540003
- UMLS CUI 2011AA
- CL426125
- UMLS CUI 2011AA
- C0013089
- SNOMED CT 2011_0131
- 68444001
- LOINC Version 232
- MTHU004184
- UMLS CUI 2011AA
- CL415123
Beschrijving
Absolute neutrophil count (ANC) at or < 1500 / mm3
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Beschrijving
Platelet count at or < 100,000 / mm3
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- SNOMED CT 2011_0131
- 365632008
- LOINC Version 232
- 777-3
Beschrijving
Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011221
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
- UMLS CUI 2011AA
- C1705302
- UMLS CUI 2011AA
- CL415123
Beschrijving
Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or > three times the upper limit of normal (if related to liver metastases at or > five times the upper limit of normal)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C0699792
- SNOMED CT 2011_0131
- 263498003
- UMLS CUI 2011AA
- C0494165
- SNOMED CT 2011_0131
- 94381002
- MedDRA 14.1
- 10027457
- ICD-10-CM Version 2010
- C78.7
- ICD-9-CM Version 2011
- 197.7
Beschrijving
Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Beschrijving
Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0025266
- SNOMED CT 2011_0131
- 339947000
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C0015671
- SNOMED CT 2011_0131
- 66839005
- LOINC Version 232
- MTHU035601
- HL7 V3 2006_05
- FTH
- UMLS CUI 2011AA
- C0008059
- SNOMED CT 2011_0131
- 67822003
- HL7 V3 2006_05
- CHILD
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C0700589
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
Beschrijving
Pregnancy or breast feeding
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0032961
- SNOMED CT 2011_0131
- 289908002
- MedDRA 14.1
- 10036556
- LOINC Version 232
- MTHU035048
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Beschrijving
Patients unable to comply with the protocol
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 371151008
Beschrijving
Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- 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
- C0019682
- SNOMED CT 2011_0131
- 19030005
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
Beschrijving
Known or suspected active drug or alcohol abuse
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0237123
Beschrijving
Interstitial lung disease (ILD)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1869044
- MedDRA 14.1
- 20000042
Beschrijving
Peripheral polyneuropathy Grade >= 2
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2673754
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
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250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
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10028211 (MedDRA 14.1)
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372540003 (SNOMED CT 2011_0131)
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10052033 (MedDRA 14.1)
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1975-2 (LOINC Version 232)
C1705302 (UMLS CUI 2011AA)
CL415123 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0494165 (UMLS CUI 2011AA)
94381002 (SNOMED CT 2011_0131)
10027457 (MedDRA 14.1)
C78.7 (ICD-10-CM Version 2010)
197.7 (ICD-9-CM Version 2011)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0015671 (UMLS CUI 2011AA)
66839005 (SNOMED CT 2011_0131)
MTHU035601 (LOINC Version 232)
FTH (HL7 V3 2006_05)
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
371151008 (SNOMED CT 2011_0131)
55561003 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
20000042 (MedDRA 14.1)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)