ID

44680

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT01232452

Länk

http://clinicaltrials.gov/show/NCT01232452

Nyckelord

Versioner (3)
  1. 2013-02-12 2013-02-12 - Martin Dugas
  2. 2014-04-19 2014-04-19 - Julian Varghese
  3. 2021-09-27 2021-09-27 -
Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT01232452 Non-Small-Cell Lung Carcinoma

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alter mindestens 18 Jahre
Beskrivning

age at least 18 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
The patient has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.
Beskrivning

The patient has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C2585890
SNOMED CT 2011_0131
440173001
UMLS CUI 2011AA
C0152013
SNOMED CT 2011_0131
254626006
MedDRA 14.1
10025031
UMLS CUI 2011AA
C0345958
SNOMED CT 2011_0131
254629004
MedDRA 14.1
10023774
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0007131
SNOMED CT 2011_0131
254637007
MedDRA 14.1
10061873
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
The patient has Stage IV disease at the time of study entry.
Beskrivning

The patient has Stage IV disease at the time of study entry.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0441772
SNOMED CT 2011_0131
258228008
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C2348558
Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
Beskrivning

Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0027767
SNOMED CT 2011_0131
18373002
UMLS CUI 2011AA
C1518543
SNOMED CT 2011_0131
420680007
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0079172
UMLS CUI 2011AA
C1520143
UMLS CUI 2011AA
C0205234
SNOMED CT 2011_0131
87017008
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0085203
SNOMED CT 2011_0131
115959002
MedDRA 14.1
10066144
ICD-9-CM Version 2011
92.30
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0332125
SNOMED CT 2011_0131
41647002
UMLS CUI 2011AA
C1560582
CTCAE 1105E
MTHU112377
UMLS CUI 2011AA
C1560583
CTCAE 1105E
MTHU113168
UMLS CUI 2011AA
C1560584
CTCAE 1105E
MTHU114179
UMLS CUI 2011AA
C1560585
CTCAE 1105E
MTHU115195
UMLS CUI 2011AA
C1560586
CTCAE 1105E
MTHU116122
The patient has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
Beskrivning

The patient has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C1518373
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1709926
UMLS CUI 2011AA
C0220845
The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Beskrivning

The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1520224
If prior adjuvant chemotherapy, the last dose of adjuvant treatment was administered at least 6 months prior to randomization.
Beskrivning

If prior adjuvant chemotherapy, the last dose of adjuvant treatment was administered at least 6 months prior to randomization.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0281265
UMLS CUI 2011AA
C1762893
LOINC Version 232
MTHU014073
UMLS CUI 2011AA
C0677850
MedDRA 14.1
10068969
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
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
The patient has adequate bone marrow reserve, and renal and hepatic function
Beskrivning

The patient has adequate bone marrow reserve, and renal and hepatic function

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C2347957
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
The patient has fasting serum glucose <= 100 mg/dL, and hemoglobin A1C <= 6%.
Beskrivning

The patient has fasting serum glucose <= 100 mg/dL, and hemoglobin A1C <= 6%.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0583334
SNOMED CT 2011_0131
167087006
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
Beskrivning

Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug.
Beskrivning

Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
The patient has the ability to understand and the willingness to sign a written informed consent form.
Beskrivning

The patient has the ability to understand and the willingness to sign a written informed consent form.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Previous radiation therapy is allowed to < 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.
Beskrivning

Previous radiation therapy is allowed to < 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL414551
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0439751
SNOMED CT 2011_0131
260232004, 255503000
UMLS CUI 2011AA
C0030797
SNOMED CT 2011_0131
12921003
LOINC Version 232
MTHU001438
The patient has archived tumor tissue available for analysis (can be either primary tumor or metastases).
Beskrivning

The patient has archived tumor tissue available for analysis (can be either primary tumor or metastases).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0003738
UMLS CUI 2011AA
C0475358
SNOMED CT 2011_0131
258435002
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
UMLS CUI 2011AA
C0002778
SNOMED CT 2011_0131
272389005
The patient has an estimated life expectancy of at least 12 weeks.
Beskrivning

The patient has an estimated life expectancy of at least 12 weeks.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205458
SNOMED CT 2011_0131
82809009
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Beskrivning

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C1096117
MedDRA 14.1
10053762
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0699733
SNOMED CT 2011_0131
49062001
LOINC Version 232
MTHU020022
Patients who have squamous histology.
Beskrivning

Patients who have squamous histology.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1182670
UMLS CUI 2011AA
C0344441
MedDRA 14.1
10062005
LOINC Version 232
MTHU010496
The patient's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
Beskrivning

The patient's tumor fully or partially contains Small Cell Lung Cancer (SCLC).

Datatyp

boolean

Alias
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
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
C0149925
SNOMED CT 2011_0131
254632001
MedDRA 14.1
10041071
Leptomeningeal disease
Beskrivning

The patient has leptomeningeal disease.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL428853
MedDRA 14.1
10070973
The patient is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC. Patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization
Beskrivning

The patient is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC. Patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0278987
MedDRA 14.1
10025055
UMLS CUI 2011AA
C0085533
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0750557
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
The patient has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
Beskrivning

The patient has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C0140079
UMLS CUI 2011AA
C0034802
SNOMED CT 2011_0131
86960007
LOINC Version 232
MTHU004296
Patients who have received prior Pemetrexed treatment.
Beskrivning

Patients who have received prior Pemetrexed treatment.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0210657
SNOMED CT 2011_0131
411089001
The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
Beskrivning

The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1705248
Diabetes mellitus
Beskrivning

The patient has diabetes mellitus.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements.
Beskrivning

The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0277557
SNOMED CT 2011_0131
88472004
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1518896
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
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
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0278060
SNOMED CT 2011_0131
36456004
LOINC Version 232
MTHU001424
CTCAE 1105E
MTHU117157
UMLS CUI 2011AA
C0851364
MedDRA 14.1
10041244
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
UMLS CUI 2011AA
C0525058
The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
Beskrivning

The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1518896
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
UMLS CUI 2011AA
C2363964
MedDRA 14.1
10068724
The patient has undergone major surgery within 28 days prior to randomization.
Beskrivning

The patient has undergone major surgery within 28 days prior to randomization.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0679637
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
The patient has received a prior autologous or allogeneic organ or tissue transplantation.
Beskrivning

The patient has received a prior autologous or allogeneic organ or tissue transplantation.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0439859
SNOMED CT 2011_0131
255379001
UMLS CUI 2011AA
C1515895
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
UMLS CUI 2011AA
C0080232
The patient is pregnant or lactating.
Beskrivning

The patient is pregnant or lactating.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
The patient has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.
Beskrivning

The patient has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1306459
SNOMED CT 2011_0131
372087000
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C1521996
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0007099
SNOMED CT 2011_0131
109355002
MedDRA 14.1
10061450
ICD-10-CM Version 2010
D09.9
ICD-9-CM Version 2011
234.9
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0280100
MedDRA 14.1
10065252
The patient has superior vena cava syndrome contraindicating hydration.
Beskrivning

The patient has superior vena cava syndrome contraindicating hydration.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0038833
SNOMED CT 2011_0131
63363004
MedDRA 14.1
10042569
CTCAE 1105E
E13819
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
CL034943
The patient has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
Beskrivning

The patient has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
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
The patient has any Grade 2 (or greater) peripheral neuropathy.
Beskrivning

The patient has any Grade 2 (or greater) peripheral neuropathy.

Datatyp

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
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
The patient has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Beskrivning

The patient has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.

Datatyp

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
C1516698
UMLS CUI 2011AA
C0003962
SNOMED CT 2011_0131
389026000
MedDRA 14.1
10003445
ICD-10-CM Version 2010
R18
ICD-9-CM Version 2011
789.5
CTCAE 1105E
E10502
UMLS CUI 2011AA
C0032227
SNOMED CT 2011_0131
60046008
MedDRA 14.1
10035598
ICD-10-CM Version 2010
J90
ICD-9-CM Version 2011
511.9
CTCAE 1105E
E13486
UMLS CUI 2011AA
C1272705
SNOMED CT 2011_0131
385671000
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
The patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <= 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Beskrivning

The patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <= 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1512900
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0031990
SNOMED CT 2011_0131
27754002
LOINC Version 232
MTHU001848
The patient is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
Beskrivning

The patient is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0033045
MedDRA 14.1
10036500
UMLS CUI 2011AA
C0016410
SNOMED CT 2011_0131
6247001
UMLS CUI 2011AA
C0042845
SNOMED CT 2011_0131
81064004
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
The patient has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.
Beskrivning

The patient has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0199823
SNOMED CT 2011_0131
67308009
MedDRA 14.1
10069614
ICD-9-CM Version 2011
99.43
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
The patient has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.
Item
The patient has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C2585890 (UMLS CUI 2011AA)
440173001 (SNOMED CT 2011_0131)
C0152013 (UMLS CUI 2011AA)
254626006 (SNOMED CT 2011_0131)
10025031 (MedDRA 14.1)
C0345958 (UMLS CUI 2011AA)
254629004 (SNOMED CT 2011_0131)
10023774 (MedDRA 14.1)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
The patient has Stage IV disease at the time of study entry.
Item
The patient has Stage IV disease at the time of study entry.
boolean
C0441772 (UMLS CUI 2011AA)
258228008 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
Item
Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
boolean
CL415147 (UMLS CUI 2011AA)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0027767 (UMLS CUI 2011AA)
18373002 (SNOMED CT 2011_0131)
C1518543 (UMLS CUI 2011AA)
420680007 (SNOMED CT 2011_0131)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0079172 (UMLS CUI 2011AA)
C1520143 (UMLS CUI 2011AA)
C0205234 (UMLS CUI 2011AA)
87017008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0085203 (UMLS CUI 2011AA)
115959002 (SNOMED CT 2011_0131)
10066144 (MedDRA 14.1)
92.30 (ICD-9-CM Version 2011)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
C1560582 (UMLS CUI 2011AA)
MTHU112377 (CTCAE 1105E)
C1560583 (UMLS CUI 2011AA)
MTHU113168 (CTCAE 1105E)
C1560584 (UMLS CUI 2011AA)
MTHU114179 (CTCAE 1105E)
C1560585 (UMLS CUI 2011AA)
MTHU115195 (CTCAE 1105E)
C1560586 (UMLS CUI 2011AA)
MTHU116122 (CTCAE 1105E)
The patient has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
Item
The patient has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
boolean
C1513040 (UMLS CUI 2011AA)
C1518373 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709926 (UMLS CUI 2011AA)
C0220845 (UMLS CUI 2011AA)
The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Item
The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
boolean
C1520224 (UMLS CUI 2011AA)
If prior adjuvant chemotherapy, the last dose of adjuvant treatment was administered at least 6 months prior to randomization.
Item
If prior adjuvant chemotherapy, the last dose of adjuvant treatment was administered at least 6 months prior to randomization.
boolean
C0750557 (UMLS CUI 2011AA)
C0281265 (UMLS CUI 2011AA)
C1762893 (UMLS CUI 2011AA)
MTHU014073 (LOINC Version 232)
C0677850 (UMLS CUI 2011AA)
10068969 (MedDRA 14.1)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
The patient has adequate bone marrow reserve, and renal and hepatic function
Item
The patient has adequate bone marrow reserve, and renal and hepatic function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C2347957 (UMLS CUI 2011AA)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
The patient has fasting serum glucose <= 100 mg/dL, and hemoglobin A1C <= 6%.
Item
The patient has fasting serum glucose <= 100 mg/dL, and hemoglobin A1C <= 6%.
boolean
C0583334 (UMLS CUI 2011AA)
167087006 (SNOMED CT 2011_0131)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
Item
Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug.
Item
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
The patient has the ability to understand and the willingness to sign a written informed consent form.
Item
The patient has the ability to understand and the willingness to sign a written informed consent form.
boolean
C0021430 (UMLS CUI 2011AA)
Previous radiation therapy is allowed to < 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.
Item
Previous radiation therapy is allowed to < 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.
boolean
CL414551 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C2825406 (UMLS CUI 2011AA)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0439751 (UMLS CUI 2011AA)
260232004, 255503000 (SNOMED CT 2011_0131)
C0030797 (UMLS CUI 2011AA)
12921003 (SNOMED CT 2011_0131)
MTHU001438 (LOINC Version 232)
The patient has archived tumor tissue available for analysis (can be either primary tumor or metastases).
Item
The patient has archived tumor tissue available for analysis (can be either primary tumor or metastases).
boolean
C0003738 (UMLS CUI 2011AA)
C0475358 (UMLS CUI 2011AA)
258435002 (SNOMED CT 2011_0131)
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C0002778 (UMLS CUI 2011AA)
272389005 (SNOMED CT 2011_0131)
The patient has an estimated life expectancy of at least 12 weeks.
Item
The patient has an estimated life expectancy of at least 12 weeks.
boolean
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205458 (UMLS CUI 2011AA)
82809009 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Item Group
Ausschlusskriterien
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Item
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
boolean
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C1096117 (UMLS CUI 2011AA)
10053762 (MedDRA 14.1)
C0013227 (UMLS CUI 2011AA)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)
Patients who have squamous histology.
Item
Patients who have squamous histology.
boolean
C1182670 (UMLS CUI 2011AA)
C0344441 (UMLS CUI 2011AA)
10062005 (MedDRA 14.1)
MTHU010496 (LOINC Version 232)
The patient's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
Item
The patient's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0149925 (UMLS CUI 2011AA)
254632001 (SNOMED CT 2011_0131)
10041071 (MedDRA 14.1)
The patient has leptomeningeal disease.
Item
Leptomeningeal disease
boolean
CL428853 (UMLS CUI 2011AA)
10070973 (MedDRA 14.1)
The patient is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC. Patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization
Item
The patient is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC. Patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0278987 (UMLS CUI 2011AA)
10025055 (MedDRA 14.1)
C0085533 (UMLS CUI 2011AA)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0750557 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
The patient has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
Item
The patient has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C1521840 (UMLS CUI 2011AA)
C0140079 (UMLS CUI 2011AA)
C0034802 (UMLS CUI 2011AA)
86960007 (SNOMED CT 2011_0131)
MTHU004296 (LOINC Version 232)
Patients who have received prior Pemetrexed treatment.
Item
Patients who have received prior Pemetrexed treatment.
boolean
C1514463 (UMLS CUI 2011AA)
C0210657 (UMLS CUI 2011AA)
411089001 (SNOMED CT 2011_0131)
The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
Item
The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
CL407060 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1705248 (UMLS CUI 2011AA)
The patient has diabetes mellitus.
Item
Diabetes mellitus
boolean
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements.
Item
The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0277557 (UMLS CUI 2011AA)
88472004 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C1518896 (UMLS CUI 2011AA)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
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)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
C0851364 (UMLS CUI 2011AA)
10041244 (MedDRA 14.1)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
Item
The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C1518896 (UMLS CUI 2011AA)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C2363964 (UMLS CUI 2011AA)
10068724 (MedDRA 14.1)
The patient has undergone major surgery within 28 days prior to randomization.
Item
The patient has undergone major surgery within 28 days prior to randomization.
boolean
C0679637 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
The patient has received a prior autologous or allogeneic organ or tissue transplantation.
Item
The patient has received a prior autologous or allogeneic organ or tissue transplantation.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0439859 (UMLS CUI 2011AA)
255379001 (SNOMED CT 2011_0131)
C1515895 (UMLS CUI 2011AA)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C0080232 (UMLS CUI 2011AA)
The patient is pregnant or lactating.
Item
The patient is pregnant or lactating.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
The patient has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.
Item
The patient has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1880198 (UMLS CUI 2011AA)
C1521996 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
CL415147 (UMLS CUI 2011AA)
C0007099 (UMLS CUI 2011AA)
109355002 (SNOMED CT 2011_0131)
10061450 (MedDRA 14.1)
D09.9 (ICD-10-CM Version 2010)
234.9 (ICD-9-CM Version 2011)
CL414904 (UMLS CUI 2011AA)
C0280100 (UMLS CUI 2011AA)
10065252 (MedDRA 14.1)
The patient has superior vena cava syndrome contraindicating hydration.
Item
The patient has superior vena cava syndrome contraindicating hydration.
boolean
C0038833 (UMLS CUI 2011AA)
63363004 (SNOMED CT 2011_0131)
10042569 (MedDRA 14.1)
E13819 (CTCAE 1105E)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
CL034943 (UMLS CUI 2011AA)
The patient has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
Item
The patient has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
boolean
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
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)
The patient has any Grade 2 (or greater) peripheral neuropathy.
Item
The patient has any Grade 2 (or greater) peripheral neuropathy.
boolean
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
The patient has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Item
The patient has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
boolean
C0205437 (UMLS CUI 2011AA)
70905002 (SNOMED CT 2011_0131)
C0229984 (UMLS CUI 2011AA)
2969000 (SNOMED CT 2011_0131)
CL427986 (UMLS CUI 2011AA)
C1516698 (UMLS CUI 2011AA)
C0003962 (UMLS CUI 2011AA)
389026000 (SNOMED CT 2011_0131)
10003445 (MedDRA 14.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE 1105E)
C0032227 (UMLS CUI 2011AA)
60046008 (SNOMED CT 2011_0131)
10035598 (MedDRA 14.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE 1105E)
C1272705 (UMLS CUI 2011AA)
385671000 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
The patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <= 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Item
The patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <= 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1512900 (UMLS CUI 2011AA)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0031990 (UMLS CUI 2011AA)
27754002 (SNOMED CT 2011_0131)
MTHU001848 (LOINC Version 232)
The patient is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
Item
The patient is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0033045 (UMLS CUI 2011AA)
10036500 (MedDRA 14.1)
C0016410 (UMLS CUI 2011AA)
6247001 (SNOMED CT 2011_0131)
C0042845 (UMLS CUI 2011AA)
81064004 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
The patient has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.
Item
The patient has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.
boolean
C1514756 (UMLS CUI 2011AA)
C0199823 (UMLS CUI 2011AA)
67308009 (SNOMED CT 2011_0131)
10069614 (MedDRA 14.1)
99.43 (ICD-9-CM Version 2011)
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