age at least 18 Years
Item
Alter mindestens 18 Jahre
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
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
Life expectancy of at least three months.
Item
Life expectancy of at least three months.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Written informed consent that is consistent with ICH-GCP guidelines.
Item
Written informed consent that is consistent with ICH-GCP guidelines.
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL371980 (UMLS CUI 2011AA)
CL426375 (UMLS CUI 2011AA)
C0220845 (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)