ID

27492

Beschrijving

BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00979576

Link

https://clinicaltrials.gov/show/NCT00979576

Trefwoorden

Versies (1)
  1. 17-11-17 17-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00979576

Engels

Eligibility Carcinoma, Non-Small-Cell Lung NCT00979576

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients of age >=20 and <=74 years at informed consent
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically or cytologically confirmed, non small cell lung cancer (nsclc) of stage iiib or iv or recurrent nsclc
Beschrijving

Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0278517
3. relapse or failure of 1 first-line prior chemotherapy
Beschrijving

Prior Chemotherapy First line Recurrent disease | Prior Chemotherapy First line failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0231175
4. life expectancy of at least 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
5. eastern cooperative oncology group (ecog) score of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
6. patients who have sufficient baseline organ function over 4 weeks and whose laboratory data meet the following criteria at the enrolment
Beschrijving

Organ function | Laboratory Results

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1254595
haemoglobin >=9.0 g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
absolute neutrophil count (anc) >=1500/mm3
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count >=100 000/mm3
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin under the upper limit of normal
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
ast/sgot and/or alt/gpt <=1.5 x upper limit of normal (if related to liver metastases <=2.5 x upper limit of normal also)
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Relationship

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0439849
proteinuria common terminology criteria for adverse events (ctcae) grade 1 or less
Beschrijving

Proteinuria CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033687
UMLS CUI [1,2]
C1516728
calculated creatinine clearance by cockcroft gault >=45 ml/min
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
prothrombin time-international normalized ratio (pt-inr) and/or partial thromboplastin time (ptt) greater than 50% deviation from normal limits
Beschrijving

Prothrombin time international normalized ratio (PT-INR) | Partial thromboplastin time

Datatype

boolean

Alias
UMLS CUI [1]
C1821762
UMLS CUI [2]
C0030605
arterial oxgen pressure (pao2) >=60 torr or oxygen saturation by pulse-oximeter spo2 >=92%
Beschrijving

Oxygen measurement, partial pressure, arterial | Measurement of oxygen saturation at periphery Pulse oximeter

Datatype

boolean

Alias
UMLS CUI [1]
C0202155
UMLS CUI [2,1]
C0428179
UMLS CUI [2,2]
C0182109
7. patient has given written informed consent which must be consistent with ich-gcp and local legislation.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia)
Beschrijving

Investigational New Drugs | Study Subject Participation Status | Investigational Therapy | Adverse effects Due to Investigational Therapy | Recovery Lacking | Exception Alopecia

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0949266
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0949266
UMLS CUI [5,1]
C2004454
UMLS CUI [5,2]
C0332268
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0002170
2. patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia) .
Beschrijving

Chemotherapy | Hormone Therapy | Immunotherapy | Monoclonal Antibodies | Small Molecule tyrosine kinase inhibitor | Adverse effects Due to Therapeutic procedure | Recovery Lacking | Exception Alopecia

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0003250
UMLS CUI [5,1]
C1328819
UMLS CUI [5,2]
C1268567
UMLS CUI [6,1]
C0879626
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0087111
UMLS CUI [7,1]
C2004454
UMLS CUI [7,2]
C0332268
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0002170
3. patients who have received radiotherapy within the following period phase i part: the past 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within the past 2 weeks prior to treatment with the trial drug)
Beschrijving

Therapeutic radiology procedure | Palliative Radiation Therapy Extremities

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C3898008
UMLS CUI [2,2]
C0015385
4. previous therapy with other vascular endothelial growth factor receptor (vegfr) inhibitors or vascular endothelial growth factor (vegf) ligand inhibitors for treatment of nsclc
Beschrijving

Vascular Endothelial Growth Factor Receptor Inhibitors Non-Small Cell Lung Carcinoma | Vascular endothelial growth factor receptor ligand Inhibitor Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C2267120
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C1749424
UMLS CUI [2,2]
C1999216
UMLS CUI [2,3]
C0007131
5. previous therapy with bibf 1120 and/or pemetrexed for treatment of nsclc and any contraindications for therapy with pemetrexed
Beschrijving

BIBF 1120 | pemetrexed | Therapeutic procedure Non-Small Cell Lung Carcinoma | Medical contraindication Pemetrexed

Datatype

boolean

Alias
UMLS CUI [1]
C1879771
UMLS CUI [2]
C0210657
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0007131
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0210657
6. patients who have active brain metastases
Beschrijving

Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
7. leptomeningeal disease
Beschrijving

Leptomeningeal disease

Datatype

boolean

Alias
UMLS CUI [1]
C3160796
8. patients with distinct or suspected pulmonary fibrosis or interstitial lung disease by the ct findings, or patients with a previous history of pulmonary fibrosis or interstitial lung disease (except irradiation-pneumonitis appearing radiation field with past radiotherapy).
Beschrijving

Pulmonary Fibrosis CT | Pulmonary Fibrosis Suspected CT | Interstitial Lung Disease CT | Interstitial Lung Disease Suspected CT | Exception Radiation Pneumonitis Radiation Field | Prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034069
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0206062
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0206062
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0206063
UMLS CUI [5,3]
C1882536
UMLS CUI [6]
C0279134
9. radiographic evidence of cavitary or necrotic tumors
Beschrijving

Tumor Cavity Radiography | Necrotic tumor Radiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1510420
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C1300818
UMLS CUI [2,2]
C0034571
10. centrally located tumors with radiographic evidence (ct or mri) of local invasion of major blood vessels
Beschrijving

Tumor Location Central | Local tumor invasion Blood Vessel Major CT | Local tumor invasion Blood Vessel Major MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205099
UMLS CUI [2,1]
C1300092
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C1300092
UMLS CUI [3,2]
C0005847
UMLS CUI [3,3]
C0205164
UMLS CUI [3,4]
C0024485
11. history of clinically significant haemoptysis within the past 3 months
Beschrijving

Hemoptysis

Datatype

boolean

Alias
UMLS CUI [1]
C0019079
12. history of major thrombotic or clinically relevant major bleeding event in the past 6 months
Beschrijving

Thrombotic episode Major | Hemorrhage Major

Datatype

boolean

Alias
UMLS CUI [1,1]
C2674163
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0205164
13. known inherited predisposition to bleeding or thrombosis
Beschrijving

Inherited Predisposition Hemorrhage | Inherited Predisposition Thrombosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0314657
UMLS CUI [1,2]
C0019080
UMLS CUI [2,1]
C0314657
UMLS CUI [2,2]
C0040053
14. significant cardiovascular diseases
Beschrijving

Cardiovascular Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
15. significant weight loss (>10%) within the past 6 weeks prior to treatment in the present trial
Beschrijving

Weight loss Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0750502
16. current peripheral neuropathy ctcae grade 2 or greater except due to trauma
Beschrijving

Peripheral Neuropathy CTCAE Grades | Exception Peripheral Neuropathy Due to Trauma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0031117
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C3714660
17. pre-existing ascites and/or clinically significant pleural effusion
Beschrijving

Ascites Pre-existing | Pleural effusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0032227
18. major injuries and/or surgery within the past 4 weeks prior to randomisation with incomplete wound healing
Beschrijving

Major injury | Major surgery | Wound, non-healed

Datatype

boolean

Alias
UMLS CUI [1]
C0332677
UMLS CUI [2]
C0679637
UMLS CUI [3]
C0750433
19. clinically serious infections
Beschrijving

Communicable Diseases Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
20. decompensated diabetes mellitus
Beschrijving

DIABETES MELLITUS DECOMPENSATED

Datatype

boolean

Alias
UMLS CUI [1]
C0743120
21. contraindication to high dose steroid therapy
Beschrijving

Medical contraindication Steroid therapy High dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0149783
UMLS CUI [1,3]
C0444956
22. gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
Beschrijving

Gastrointestinal Diseases Interfere with Absorption Investigational New Drugs | Abnormality of the gastrointestinal tract Interferes with Absorption Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C4023588
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
23. patients who have active or chronic hepatitis c and/or b infection and diagnosis of human immunodeficiency virus (hiv) infection
Beschrijving

Hepatitis C | Hepatitis B | Hepatitis C, Chronic | Hepatitis B, Chronic | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0524910
UMLS CUI [4]
C0524909
UMLS CUI [5]
C0019693
24. other malignancy other than basal cell skin cancer, carcinoma in situ or intra-mucosal cancer that were judged to be cured by adequate treatment and disease-free interval is more than 5 years
Beschrijving

Cancer Other | Exception Basal cell carcinoma cured | Exception Carcinoma in Situ cured | Exception Cancer Mucosa cured

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0184780
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C0184780
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C0026724
UMLS CUI [4,4]
C0184780
25. history of serious drug hypersensitivity
Beschrijving

Drug Allergy Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205404
26. serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation
Beschrijving

Illness Serious Study Subject Participation Status At risk | Comorbidity Serious Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Nervous system disorder | Mental disorders | Communicable Disease | Gastrointestinal ulcer | Skin Ulcer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0009450
UMLS CUI [7]
C0237938
UMLS CUI [8]
C0037299
27. therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy
Beschrijving

Anticoagulation Therapy | Exception Heparin Low dose | Exception Heparin flush | Antiplatelet therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019134
UMLS CUI [2,3]
C0445550
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0354589
UMLS CUI [4]
C1096021
28. patients who are sexually active and unwilling to use a medically acceptable method of contraception
Beschrijving

Sexually active Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
29. pregnancy or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
30. active alcohol or drug abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
31. patients unable to comply with the protocol
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
32. other patients judged ineligible for enrolment in the study by the investigator or subinvestigator.
Beschrijving

Study Subject Participation Status Ineligible

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00979576

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female patients of age >=20 and <=74 years at informed consent
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent
Item
2. histologically or cytologically confirmed, non small cell lung cancer (nsclc) of stage iiib or iv or recurrent nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2])
Prior Chemotherapy First line Recurrent disease | Prior Chemotherapy First line failed
Item
3. relapse or failure of 1 first-line prior chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Life Expectancy
Item
4. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function | Laboratory Results
Item
6. patients who have sufficient baseline organ function over 4 weeks and whose laboratory data meet the following criteria at the enrolment
boolean
C0678852 (UMLS CUI [1])
C1254595 (UMLS CUI [2])
Hemoglobin measurement
Item
haemoglobin >=9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >=1500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >=100 000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin under the upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Relationship
Item
ast/sgot and/or alt/gpt <=1.5 x upper limit of normal (if related to liver metastases <=2.5 x upper limit of normal also)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
Proteinuria CTCAE Grades
Item
proteinuria common terminology criteria for adverse events (ctcae) grade 1 or less
boolean
C0033687 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance by cockcroft gault >=45 ml/min
boolean
C2711451 (UMLS CUI [1])
Prothrombin time international normalized ratio (PT-INR) | Partial thromboplastin time
Item
prothrombin time-international normalized ratio (pt-inr) and/or partial thromboplastin time (ptt) greater than 50% deviation from normal limits
boolean
C1821762 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Oxygen measurement, partial pressure, arterial | Measurement of oxygen saturation at periphery Pulse oximeter
Item
arterial oxgen pressure (pao2) >=60 torr or oxygen saturation by pulse-oximeter spo2 >=92%
boolean
C0202155 (UMLS CUI [1])
C0428179 (UMLS CUI [2,1])
C0182109 (UMLS CUI [2,2])
Informed Consent
Item
7. patient has given written informed consent which must be consistent with ich-gcp and local legislation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Study Subject Participation Status | Investigational Therapy | Adverse effects Due to Investigational Therapy | Recovery Lacking | Exception Alopecia
Item
1. patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia)
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
C0879626 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0949266 (UMLS CUI [4,3])
C2004454 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0002170 (UMLS CUI [6,2])
Chemotherapy | Hormone Therapy | Immunotherapy | Monoclonal Antibodies | Small Molecule tyrosine kinase inhibitor | Adverse effects Due to Therapeutic procedure | Recovery Lacking | Exception Alopecia
Item
2. patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia) .
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0003250 (UMLS CUI [4])
C1328819 (UMLS CUI [5,1])
C1268567 (UMLS CUI [5,2])
C0879626 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0087111 (UMLS CUI [6,3])
C2004454 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0002170 (UMLS CUI [8,2])
Therapeutic radiology procedure | Palliative Radiation Therapy Extremities
Item
3. patients who have received radiotherapy within the following period phase i part: the past 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within the past 2 weeks prior to treatment with the trial drug)
boolean
C1522449 (UMLS CUI [1])
C3898008 (UMLS CUI [2,1])
C0015385 (UMLS CUI [2,2])
Vascular Endothelial Growth Factor Receptor Inhibitors Non-Small Cell Lung Carcinoma | Vascular endothelial growth factor receptor ligand Inhibitor Non-Small Cell Lung Carcinoma
Item
4. previous therapy with other vascular endothelial growth factor receptor (vegfr) inhibitors or vascular endothelial growth factor (vegf) ligand inhibitors for treatment of nsclc
boolean
C2267120 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1749424 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
BIBF 1120 | pemetrexed | Therapeutic procedure Non-Small Cell Lung Carcinoma | Medical contraindication Pemetrexed
Item
5. previous therapy with bibf 1120 and/or pemetrexed for treatment of nsclc and any contraindications for therapy with pemetrexed
boolean
C1879771 (UMLS CUI [1])
C0210657 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0210657 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain
Item
6. patients who have active brain metastases
boolean
C0220650 (UMLS CUI [1])
Leptomeningeal disease
Item
7. leptomeningeal disease
boolean
C3160796 (UMLS CUI [1])
Pulmonary Fibrosis CT | Pulmonary Fibrosis Suspected CT | Interstitial Lung Disease CT | Interstitial Lung Disease Suspected CT | Exception Radiation Pneumonitis Radiation Field | Prior radiation therapy
Item
8. patients with distinct or suspected pulmonary fibrosis or interstitial lung disease by the ct findings, or patients with a previous history of pulmonary fibrosis or interstitial lung disease (except irradiation-pneumonitis appearing radiation field with past radiotherapy).
boolean
C0034069 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0206062 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0206062 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0206063 (UMLS CUI [5,2])
C1882536 (UMLS CUI [5,3])
C0279134 (UMLS CUI [6])
Tumor Cavity Radiography | Necrotic tumor Radiography
Item
9. radiographic evidence of cavitary or necrotic tumors
boolean
C0027651 (UMLS CUI [1,1])
C1510420 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C1300818 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
Tumor Location Central | Local tumor invasion Blood Vessel Major CT | Local tumor invasion Blood Vessel Major MRI
Item
10. centrally located tumors with radiographic evidence (ct or mri) of local invasion of major blood vessels
boolean
C0027651 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205099 (UMLS CUI [1,3])
C1300092 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1300092 (UMLS CUI [3,1])
C0005847 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
Hemoptysis
Item
11. history of clinically significant haemoptysis within the past 3 months
boolean
C0019079 (UMLS CUI [1])
Thrombotic episode Major | Hemorrhage Major
Item
12. history of major thrombotic or clinically relevant major bleeding event in the past 6 months
boolean
C2674163 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Inherited Predisposition Hemorrhage | Inherited Predisposition Thrombosis
Item
13. known inherited predisposition to bleeding or thrombosis
boolean
C0314657 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0314657 (UMLS CUI [2,1])
C0040053 (UMLS CUI [2,2])
Cardiovascular Diseases
Item
14. significant cardiovascular diseases
boolean
C0007222 (UMLS CUI [1])
Weight loss Significant
Item
15. significant weight loss (>10%) within the past 6 weeks prior to treatment in the present trial
boolean
C1262477 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades | Exception Peripheral Neuropathy Due to Trauma
Item
16. current peripheral neuropathy ctcae grade 2 or greater except due to trauma
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0031117 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3714660 (UMLS CUI [2,4])
Ascites Pre-existing | Pleural effusion
Item
17. pre-existing ascites and/or clinically significant pleural effusion
boolean
C0003962 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
Major injury | Major surgery | Wound, non-healed
Item
18. major injuries and/or surgery within the past 4 weeks prior to randomisation with incomplete wound healing
boolean
C0332677 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0750433 (UMLS CUI [3])
Communicable Diseases Serious
Item
19. clinically serious infections
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
DIABETES MELLITUS DECOMPENSATED
Item
20. decompensated diabetes mellitus
boolean
C0743120 (UMLS CUI [1])
Medical contraindication Steroid therapy High dose
Item
21. contraindication to high dose steroid therapy
boolean
C1301624 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
Gastrointestinal Diseases Interfere with Absorption Investigational New Drugs | Abnormality of the gastrointestinal tract Interferes with Absorption Investigational New Drugs
Item
22. gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C4023588 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Hepatitis C | Hepatitis B | Hepatitis C, Chronic | Hepatitis B, Chronic | HIV Infection
Item
23. patients who have active or chronic hepatitis c and/or b infection and diagnosis of human immunodeficiency virus (hiv) infection
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Cancer Other | Exception Basal cell carcinoma cured | Exception Carcinoma in Situ cured | Exception Cancer Mucosa cured
Item
24. other malignancy other than basal cell skin cancer, carcinoma in situ or intra-mucosal cancer that were judged to be cured by adequate treatment and disease-free interval is more than 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0184780 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C0184780 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0026724 (UMLS CUI [4,3])
C0184780 (UMLS CUI [4,4])
Drug Allergy Serious
Item
25. history of serious drug hypersensitivity
boolean
C0013182 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Illness Serious Study Subject Participation Status At risk | Comorbidity Serious Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Nervous system disorder | Mental disorders | Communicable Disease | Gastrointestinal ulcer | Skin Ulcer
Item
26. serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C0438215 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0027765 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0237938 (UMLS CUI [7])
C0037299 (UMLS CUI [8])
Anticoagulation Therapy | Exception Heparin Low dose | Exception Heparin flush | Antiplatelet therapy
Item
27. therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy
boolean
C0003281 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0354589 (UMLS CUI [3,2])
C1096021 (UMLS CUI [4])
Sexually active Contraceptive methods Unwilling
Item
28. patients who are sexually active and unwilling to use a medically acceptable method of contraception
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
29. pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
30. active alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Protocol Compliance Unable
Item
31. patients unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status Ineligible
Item
32. other patients judged ineligible for enrolment in the study by the investigator or subinvestigator.
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
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