ID
44616
Description
ODM derived from http://clinicaltrials.gov/show/NCT01085136
Link
http://clinicaltrials.gov/show/NCT01085136
Keywords
Versions (3)
- 12/6/13 12/6/13 - Martin Dugas
- 4/17/14 4/17/14 - Julian Varghese
- 9/27/21 9/27/21 -
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01085136 Carcinoma, Non-Small-Cell Lung
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
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)
Data type
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
Description
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.
Data type
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
Description
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
Data type
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
Description
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
Data type
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
Description
Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
Data type
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
Description
Radiotherapy within the past 2 weeks prior to treatment with the trial drug
Data type
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
Description
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
Data type
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
Description
Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
Data type
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
Description
QTc interval at or > 0.47 second
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0489625
- LOINC Version 232
- MTHU024527
Description
Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2
Data type
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
Description
Absolute neutrophil count (ANC) at or < 1500 / mm3
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Description
Platelet count at or < 100,000 / mm3
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- SNOMED CT 2011_0131
- 365632008
- LOINC Version 232
- 777-3
Description
Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0011221
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
- UMLS CUI 2011AA
- C1705302
- UMLS CUI 2011AA
- CL415123
Description
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)
Data type
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
Description
Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min
Data type
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
Description
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
Data type
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
Description
Pregnancy or breast feeding
Data type
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
Description
Patients unable to comply with the protocol
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 371151008
Description
Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- 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
- 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
Description
Known or suspected active drug or alcohol abuse
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0237123
Description
Interstitial lung disease (ILD)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1869044
- MedDRA 14.1
- 20000042
Description
Peripheral polyneuropathy Grade >= 2
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2673754
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
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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)
C0009450 (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)