ID

5046

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00949650

Länk

http://clinicaltrials.gov/show/NCT00949650

Nyckelord

Versioner (2)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2014-04-17 2014-04-17 - Julian Varghese
Uppladdad den

17 april 2014

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00949650 Carcinoma, Non-Small-Cell Lung

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Beskrivning

age at least 18 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
Beskrivning

Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0862793
MedDRA 14.1
10001183
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
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
C0031039
SNOMED CT 2011_0131
373945007
MedDRA 14.1
10034474
CTCAE 1105E
E10172
UMLS CUI 2011AA
C0854988
SNOMED CT 2011_0131
424993006
MedDRA 14.1
10025038
Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
Beskrivning

Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0034802
SNOMED CT 2011_0131
86960007
LOINC Version 232
MTHU004296
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
UMLS CUI 2011AA
C1880016
UMLS CUI 2011AA
C0002778
SNOMED CT 2011_0131
272389005
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
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0520510
SNOMED CT 2011_0131
260769002
LOINC Version 232
MTHU013790
HL7 V3 2006_05
MAT
Measurable disease according to RECIST 1.1.
Beskrivning

Measurable disease according to RECIST 1.1.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1709926
Eastern Cooperative Oncology Group score of 0 or 1.
Beskrivning

Eastern Cooperative Oncology Group score of 0 or 1.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1520224
Life expectancy of at least three months.
Beskrivning

Life expectancy of at least three months.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0023671
Written informed consent that is consistent with ICH-GCP guidelines.
Beskrivning

Written informed consent that is consistent with ICH-GCP guidelines.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
Beskrivning

Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0007131
SNOMED CT 2011_0131
254637007
MedDRA 14.1
10061873
UMLS CUI 2011AA
C0278987
MedDRA 14.1
10025055
Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
Beskrivning

Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0034802
SNOMED CT 2011_0131
86960007
LOINC Version 232
MTHU004296
UMLS CUI 2011AA
CL421608
UMLS CUI 2011AA
C0700321
SNOMED CT 2011_0131
255507004
UMLS CUI 2011AA
C0567416
SNOMED CT 2011_0131
290005005
UMLS CUI 2011AA
C0003241
SNOMED CT 2011_0131
68498002
LOINC Version 232
MTHU003502
Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
Beskrivning

Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
Active brain metastases
Beskrivning

Active brain metastases

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
Any other current malignancy or malignancy diagnosed within the past five years
Beskrivning

Any other current malignancy or malignancy diagnosed within the past five years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
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
C0332132
SNOMED CT 2011_0131
48318009
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Known pre-existing interstitial lung disease.
Beskrivning

Known pre-existing interstitial lung disease.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0206062
SNOMED CT 2011_0131
233703007
MedDRA 14.1
10022611
ICD-10-CM Version 2010
J84.9
Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
Beskrivning

Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.

Datatyp

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
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
History or presence of clinically relevant cardiovascular abnormalities.
Beskrivning

History or presence of clinically relevant cardiovascular abnormalities.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0243050
SNOMED CT 2011_0131
9904008
MedDRA 14.1
10061054
Any other concomitant serious illness or organ system dysfunction.
Beskrivning

Any other concomitant serious illness or organ system dysfunction.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0243087
UMLS CUI 2011AA
C0460002
SNOMED CT 2011_0131
91689009
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
Adequate absolute neutrophil count and platelet count
Beskrivning

Adequate absolute neutrophil count and platelet count

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
Adequate liver and kidney function
Beskrivning

Adequate liver and kidney function

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
Beskrivning

Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
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
UMLS CUI 2011AA
C0853961
MedDRA 14.1
10020159
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Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
Item
Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
boolean
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0862793 (UMLS CUI 2011AA)
10001183 (MedDRA 14.1)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
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)
C0031039 (UMLS CUI 2011AA)
373945007 (SNOMED CT 2011_0131)
10034474 (MedDRA 14.1)
E10172 (CTCAE 1105E)
C0854988 (UMLS CUI 2011AA)
424993006 (SNOMED CT 2011_0131)
10025038 (MedDRA 14.1)
Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
Item
Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
boolean
C0034802 (UMLS CUI 2011AA)
86960007 (SNOMED CT 2011_0131)
MTHU004296 (LOINC Version 232)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C1880016 (UMLS CUI 2011AA)
C0002778 (UMLS CUI 2011AA)
272389005 (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)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0520510 (UMLS CUI 2011AA)
260769002 (SNOMED CT 2011_0131)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
Measurable disease according to RECIST 1.1.
Item
Measurable disease according to RECIST 1.1.
boolean
C1513040 (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)
Eastern Cooperative Oncology Group score of 0 or 1.
Item
Eastern Cooperative Oncology Group score of 0 or 1.
boolean
C1520224 (UMLS CUI 2011AA)
Life expectancy of at least three months.
Item
Life expectancy of at least three months.
boolean
C0023671 (UMLS CUI 2011AA)
Written informed consent that is consistent with ICH-GCP guidelines.
Item
Written informed consent that is consistent with ICH-GCP guidelines.
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
Item
Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
boolean
C1514457 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (MedDRA 14.1)
C0278987 (UMLS CUI 2011AA)
10025055 (MedDRA 14.1)
Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
Item
Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
boolean
C1514463 (UMLS CUI 2011AA)
C0034802 (UMLS CUI 2011AA)
86960007 (SNOMED CT 2011_0131)
MTHU004296 (LOINC Version 232)
CL421608 (UMLS CUI 2011AA)
C0700321 (UMLS CUI 2011AA)
255507004 (SNOMED CT 2011_0131)
C0567416 (UMLS CUI 2011AA)
290005005 (SNOMED CT 2011_0131)
C0003241 (UMLS CUI 2011AA)
68498002 (SNOMED CT 2011_0131)
MTHU003502 (LOINC Version 232)
Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
Item
Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
boolean
C0034619 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
Active brain metastases
Item
Active brain metastases
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
Any other current malignancy or malignancy diagnosed within the past five years
Item
Any other current malignancy or malignancy diagnosed within the past five years
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (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)
C0332132 (UMLS CUI 2011AA)
48318009 (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)
Known pre-existing interstitial lung disease.
Item
Known pre-existing interstitial lung disease.
boolean
C2347662 (UMLS CUI 2011AA)
C0206062 (UMLS CUI 2011AA)
233703007 (SNOMED CT 2011_0131)
10022611 (MedDRA 14.1)
J84.9 (ICD-10-CM Version 2010)
Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
Item
Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0011991 (UMLS CUI 2011AA)
62315008 (SNOMED CT 2011_0131)
10012735 (MedDRA 14.1)
MTHU013347 (LOINC Version 232)
R19.7 (ICD-10-CM Version 2010)
787.91 (ICD-9-CM Version 2011)
E10572 (CTCAE 1105E)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
History or presence of clinically relevant cardiovascular abnormalities.
Item
History or presence of clinically relevant cardiovascular abnormalities.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0243050 (UMLS CUI 2011AA)
9904008 (SNOMED CT 2011_0131)
10061054 (MedDRA 14.1)
Any other concomitant serious illness or organ system dysfunction.
Item
Any other concomitant serious illness or organ system dysfunction.
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0243087 (UMLS CUI 2011AA)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
Adequate absolute neutrophil count and platelet count
Item
Adequate absolute neutrophil count and platelet count
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Adequate liver and kidney function
Item
Adequate liver and kidney function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
Item
Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (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)
C0853961 (UMLS CUI 2011AA)
10020159 (MedDRA 14.1)
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