ID

41189

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01562028

Nyckelord

Versioner (1)
  1. 2020-07-08 2020-07-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 juli 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT01562028

Engelsk

Eligibility Lung Cancer NCT01562028

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

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

Datatyp

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)
Beskrivning

Non-squamous non-small cell lung cancer

Datatyp

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)
Beskrivning

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

Datatyp

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).
Beskrivning

Measurable Disease | Evaluable Disease

Datatyp

boolean

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

EGFR exon 19 deletion | EGFR Exon 21 Mutation

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with increased risk of bleeding
Beskrivning

High risk of bleeding

Datatyp

boolean

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

Cardiovascular Disease

Datatyp

boolean

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

Thrombosis | Thromboembolism

Datatyp

boolean

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

Gastrointestinal problem

Datatyp

boolean

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

Nervous system problem

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Anomaly of eye Surface of eye

Datatyp

boolean

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

Prior Chemotherapy Neoplasm Metastasis

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Lung Cancer NCT01562028

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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