ID

41189

Descripción

BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01562028

Link

https://clinicaltrials.gov/show/NCT01562028

Palabras clave

Versiones (1)
  1. 8/7/20 8/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de julio de 2020

DOI

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Licencia

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT01562028

Inglés

Eligibility Lung Cancer NCT01562028

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate haematological function, coagulation, liver function and renal function
Descripción

Hematologic function | Coagulation function analysis | Liver function | Renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C3516400
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0232804
pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (nsclc)
Descripción

Non-squamous non-small cell lung cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4324656
tnm version 7 stage iv disease including m1a (malignant effusion) or m1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage iii disease)
Descripción

Disease TNM clinical staging | Advanced disease Locally | Disease Inappropriate Curative treatment | Disease Progression | Status post Chemoradiotherapy Disease TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0679246
UMLS CUI [2,2]
C1517927
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1273390
UMLS CUI [4]
C0242656
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0436307
UMLS CUI [5,3]
C0012634
UMLS CUI [5,4]
C3258246
measurable or evaluable disease (according to recist 1.1 criteria).
Descripción

Measurable Disease | Evaluable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
centrally confirmed egfr exon 19 deletion (del19) or exon 21 mutation (l858r)
Descripción

EGFR exon 19 deletion | EGFR Exon 21 Mutation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3889117
UMLS CUI [2]
C4289654
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with increased risk of bleeding
Descripción

High risk of bleeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4039184
patients with clinically significant cardiovascular diseases
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
patients with a history of thrombosis or thromboembolism in the 6 months prior to treatment
Descripción

Thrombosis | Thromboembolism

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0040038
patients with gastrointestinal problems
Descripción

Gastrointestinal problem

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017187
patients with neurologic problems
Descripción

Nervous system problem

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221571
C0154091 patients who have had in the past 5 years any previous or concomitant malignancy except adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.
Descripción

Malignant Neoplasm | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of bladder Treated | Exception Carcinoma in situ of female breast Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0154091
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0686288
UMLS CUI [6,3]
C1522326
patients with any known significant ophthalmologic anomaly of the ocular surface
Descripción

Anomaly of eye Surface of eye

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4076038
UMLS CUI [1,2]
C4321570
patients who received prior chemotherapy for metastatic disease
Descripción

Prior Chemotherapy Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
patients who received previous treatment for lung cancer with drugs targeting egfr or vegf
Descripción

Prior Therapy Malignant neoplasm of lung | EGFR targeted therapy | VEGF targeted therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0242379
UMLS CUI [2]
C4733187
UMLS CUI [3]
C4733192
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Lung Cancer NCT01562028

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Coagulation function analysis | Liver function | Renal function
Item
adequate haematological function, coagulation, liver function and renal function
boolean
C0221130 (UMLS CUI [1])
C3516400 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
Non-squamous non-small cell lung cancer
Item
pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (nsclc)
boolean
C4324656 (UMLS CUI [1])
Disease TNM clinical staging | Advanced disease Locally | Disease Inappropriate Curative treatment | Disease Progression | Status post Chemoradiotherapy Disease TNM clinical staging
Item
tnm version 7 stage iv disease including m1a (malignant effusion) or m1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage iii disease)
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0679246 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1273390 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0436307 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C3258246 (UMLS CUI [5,4])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease (according to recist 1.1 criteria).
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
EGFR exon 19 deletion | EGFR Exon 21 Mutation
Item
centrally confirmed egfr exon 19 deletion (del19) or exon 21 mutation (l858r)
boolean
C3889117 (UMLS CUI [1])
C4289654 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
High risk of bleeding
Item
patients with increased risk of bleeding
boolean
C4039184 (UMLS CUI [1])
Cardiovascular Disease
Item
patients with clinically significant cardiovascular diseases
boolean
C0007222 (UMLS CUI [1])
Thrombosis | Thromboembolism
Item
patients with a history of thrombosis or thromboembolism in the 6 months prior to treatment
boolean
C0040053 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
Gastrointestinal problem
Item
patients with gastrointestinal problems
boolean
C0017187 (UMLS CUI [1])
Nervous system problem
Item
patients with neurologic problems
boolean
C0221571 (UMLS CUI [1])
Malignant Neoplasm | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of bladder Treated | Exception Carcinoma in situ of female breast Treated
Item
C0154091 patients who have had in the past 5 years any previous or concomitant malignancy except adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0154091 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0686288 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
Anomaly of eye Surface of eye
Item
patients with any known significant ophthalmologic anomaly of the ocular surface
boolean
C4076038 (UMLS CUI [1,1])
C4321570 (UMLS CUI [1,2])
Prior Chemotherapy Neoplasm Metastasis
Item
patients who received prior chemotherapy for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Prior Therapy Malignant neoplasm of lung | EGFR targeted therapy | VEGF targeted therapy
Item
patients who received previous treatment for lung cancer with drugs targeting egfr or vegf
boolean
C1514463 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
C4733187 (UMLS CUI [2])
C4733192 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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