0 Avaliações
ID

44468

Descrição

The Efficacy and Safety of Apatinib in Heavily Pretreated Advanced Non-squamous Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02515435

Link

https://clinicaltrials.gov/show/NCT02515435

Palavras-chave

Versões (2)
  1. 31/05/2019 31/05/2019 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Non-Small Cell Lung Cancer NCT02515435

    Inglês

    Eligibility Non-Small Cell Lung Cancer NCT02515435

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. obtain of informed consent.
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    2. aged 18 years and over.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    3. histologically or cytologically confirmed non-squamous non-small cell lung cancer.
    Descrição

    Non-Squamous Non-Small Cell Lung Carcinoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4324656 (Non-squamous non-small cell lung cancer)
    4. world health organization (who) performance status (ps) of 0 to 3.
    Descrição

    WHO performance status scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1298650 (WHO performance status scale)
    SNOMED
    373801008
    5. measurable lesions as defined by recist criteria.
    Descrição

    Measurable lesion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    6. life expectancy ≥12 weeks.
    Descrição

    Life Expectancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    7. organ functions normal, as defined below, within two weeks of randomization:
    Descrição

    Organ function

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0678852 (body system or organ function)
    hb≥90g/l absolute neutrophils count(anc)≥1.5×109/l platelets≥80×109/l serum bilirubin≤2×uln; aspartate transaminase(ast) and alanine transaminase (alt)≤2.5×uln(≤5×uln if liver metastases) creatinine clearance≥45ml/min or cr≤1.25×uln
    Descrição

    Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine clearance measurement | Creatinine measurement, serum

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0518015 (Hemoglobin measurement)
    UMLS CUI [2]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [3]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    UMLS CUI [4]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [5]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI [6]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [7]
    C0494165 (Secondary malignant neoplasm of liver)
    SNOMED
    94381002
    UMLS CUI [8]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    UMLS CUI [9]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    8. females of child-bearing potential must have negative serum pregnancy test. sexually active males and females (of childbearing potential) willing to practice contraception during the study.
    Descrição

    Childbearing Potential Serum pregnancy test negative | Gender Sexually active Contraceptive methods | Childbearing Potential Sexually active Contraceptive methods

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0430061 (Serum pregnancy test negative)
    SNOMED
    166435006
    UMLS CUI [2,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2,2]
    C0241028 (Sexually active)
    SNOMED
    228453005
    UMLS CUI [2,3]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [3,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [3,2]
    C0241028 (Sexually active)
    SNOMED
    228453005
    UMLS CUI [3,3]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
    Descrição

    Squamous cell carcinoma | Adenosquamous carcinoma | Small cell carcinoma of lung

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007137 (Squamous cell carcinoma)
    SNOMED
    28899001
    LOINC
    LP17968-6
    UMLS CUI [2]
    C0206623 (Adenosquamous carcinoma)
    SNOMED
    403902008
    LOINC
    LA15446-0
    UMLS CUI [3]
    C0149925 (Small cell carcinoma of lung)
    SNOMED
    254632001
    2. newly diagnosed central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation.
    Descrição

    CNS metastases | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0686377 (CNS metastases)
    SNOMED
    94243009
    UMLS CUI [2,1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [2,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [3,1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [3,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    3. tumor invade big vessels or close to big vessels (less than 5mm)
    Descrição

    Tumor Invasion Blood vessels big

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1269955 (Tumor Cell Invasion)
    UMLS CUI [1,2]
    C0005847 (Blood Vessel)
    SNOMED
    59820001
    LOINC
    LP220354-7
    UMLS CUI [1,3]
    C0549177 (Large)
    SNOMED
    255509001
    LOINC
    LA8981-8
    4. obvious cavity or necrosis formed in the tumor
    Descrição

    Cavity Formed Tumor | Necrosis Formed Tumor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0333343 (Body cavities)
    SNOMED
    91806002
    UMLS CUI [1,2]
    C0205431 (Formed)
    SNOMED
    35810008
    UMLS CUI [1,3]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    UMLS CUI [2,1]
    C0027540 (Necrosis)
    SNOMED
    6574001
    LOINC
    LA19119-9
    UMLS CUI [2,2]
    C0205431 (Formed)
    SNOMED
    35810008
    UMLS CUI [2,3]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    5. uncontrolled hypertension
    Descrição

    Uncontrolled hypertension

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1868885 (Uncontrolled hypertension)
    6. myocardial ischemia or infarction more than stage ii, cardiac insufficiency.
    Descrição

    Myocardial Ischemia Stage | Myocardial Infarction Stage | Heart failure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0151744 (Myocardial Ischemia)
    SNOMED
    414545008
    UMLS CUI [1,2]
    C1306673 (Stage)
    SNOMED
    258214002
    LOINC
    LP73395-3
    UMLS CUI [2,1]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    UMLS CUI [2,2]
    C1306673 (Stage)
    SNOMED
    258214002
    LOINC
    LP73395-3
    UMLS CUI [3]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    7. abnormal coagulation (inr>1.5 or pt>uln+4, or aptt>1.5 uln), bleeding tendency or receiving coagulation therapy
    Descrição

    Blood Coagulation Disorders | INR raised | Prothrombin time increased | Prolonged activated partial prothrombin time (aPPT) | Bleeding tendency | Coagulation therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    UMLS CUI [2]
    C0853225 (INR Increased)
    SNOMED
    313341008
    UMLS CUI [3]
    C0151872 (Prothrombin time increased (finding))
    SNOMED
    409674002
    UMLS CUI [4]
    C1846819 (Prolonged activated partial prothrombin time (aPPT))
    UMLS CUI [5]
    C1458140 (Bleeding tendency)
    SNOMED
    64779008
    LOINC
    LA20352-3
    UMLS CUI [6]
    C0441509 (Coagulation procedure)
    SNOMED
    119266004
    8. hemoptysis, more than 2.5ml daily
    Descrição

    Hemoptysis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019079 (Hemoptysis)
    SNOMED
    66857006
    LOINC
    LA29583-4
    9. thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
    Descrição

    Thrombosis | Pulmonary thrombosis | Cerebrovascular accident | Deep Vein Thrombosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0040053 (Thrombosis)
    SNOMED
    118927008
    LOINC
    LP31622-1
    UMLS CUI [2]
    C0151946 (Pulmonary thrombosis)
    SNOMED
    69357003
    UMLS CUI [3]
    C0038454 (Cerebrovascular accident)
    SNOMED
    230690007
    LOINC
    MTHU020801
    UMLS CUI [4]
    C0149871 (Deep Vein Thrombosis)
    SNOMED
    128053003
    10. unhealed bone fracture or wound for long time
    Descrição

    Bone fracture Non-healed Long-term | Non-healed wound Long-term

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0016658 (Fracture)
    SNOMED
    72704001
    LOINC
    LA7437-2
    UMLS CUI [1,2]
    C0205301 (Non-healed)
    SNOMED
    26449002
    UMLS CUI [1,3]
    C0443252 (Long-term)
    UMLS CUI [2,1]
    C0750433 (Wound, non-healed)
    SNOMED
    125192008
    UMLS CUI [2,2]
    C0443252 (Long-term)
    11. received big surgery, had bone fracture or ulcer in 4 weeks.
    Descrição

    Major surgery | Bone fracture | Ulcer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0679637 (major surgery)
    UMLS CUI [2]
    C0016658 (Fracture)
    SNOMED
    72704001
    LOINC
    LA7437-2
    UMLS CUI [3]
    C0041582 (Ulcer)
    SNOMED
    429040005
    LOINC
    MTHU022920
    12. urine protein≥++, or urine protein in 24 hours≥1.0g
    Descrição

    Urinary protein increased | 24 Hour Urine Protein Test

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0858667 (Urinary protein increased)
    UMLS CUI [2]
    C1254855 (24 Hour Urine Protein Test)
    13. pregnant or lactating woman.
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
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    Similar models

    Eligibility Non-Small Cell Lung Cancer NCT02515435

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    1. obtain of informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    2. aged 18 years and over.
    boolean
    C0001779 (UMLS CUI [1])
    Non-Squamous Non-Small Cell Lung Carcinoma
    Item
    3. histologically or cytologically confirmed non-squamous non-small cell lung cancer.
    boolean
    C4324656 (UMLS CUI [1])
    WHO performance status scale
    Item
    4. world health organization (who) performance status (ps) of 0 to 3.
    boolean
    C1298650 (UMLS CUI [1])
    Measurable lesion
    Item
    5. measurable lesions as defined by recist criteria.
    boolean
    C1513041 (UMLS CUI [1])
    Life Expectancy
    Item
    6. life expectancy ≥12 weeks.
    boolean
    C0023671 (UMLS CUI [1])
    Organ function
    Item
    7. organ functions normal, as defined below, within two weeks of randomization:
    boolean
    C0678852 (UMLS CUI [1])
    Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine clearance measurement | Creatinine measurement, serum
    Item
    hb≥90g/l absolute neutrophils count(anc)≥1.5×109/l platelets≥80×109/l serum bilirubin≤2×uln; aspartate transaminase(ast) and alanine transaminase (alt)≤2.5×uln(≤5×uln if liver metastases) creatinine clearance≥45ml/min or cr≤1.25×uln
    boolean
    C0518015 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    C0201899 (UMLS CUI [5])
    C0201836 (UMLS CUI [6])
    C0494165 (UMLS CUI [7])
    C0373595 (UMLS CUI [8])
    C0201976 (UMLS CUI [9])
    Childbearing Potential Serum pregnancy test negative | Gender Sexually active Contraceptive methods | Childbearing Potential Sexually active Contraceptive methods
    Item
    8. females of child-bearing potential must have negative serum pregnancy test. sexually active males and females (of childbearing potential) willing to practice contraception during the study.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430061 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C0241028 (UMLS CUI [2,2])
    C0700589 (UMLS CUI [2,3])
    C3831118 (UMLS CUI [3,1])
    C0241028 (UMLS CUI [3,2])
    C0700589 (UMLS CUI [3,3])
    Item Group
    C0680251 (UMLS CUI)
    Squamous cell carcinoma | Adenosquamous carcinoma | Small cell carcinoma of lung
    Item
    1. squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
    boolean
    C0007137 (UMLS CUI [1])
    C0206623 (UMLS CUI [2])
    C0149925 (UMLS CUI [3])
    CNS metastases | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent
    Item
    2. newly diagnosed central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation.
    boolean
    C0686377 (UMLS CUI [1])
    C0543467 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Tumor Invasion Blood vessels big
    Item
    3. tumor invade big vessels or close to big vessels (less than 5mm)
    boolean
    C1269955 (UMLS CUI [1,1])
    C0005847 (UMLS CUI [1,2])
    C0549177 (UMLS CUI [1,3])
    Cavity Formed Tumor | Necrosis Formed Tumor
    Item
    4. obvious cavity or necrosis formed in the tumor
    boolean
    C0333343 (UMLS CUI [1,1])
    C0205431 (UMLS CUI [1,2])
    C0027651 (UMLS CUI [1,3])
    C0027540 (UMLS CUI [2,1])
    C0205431 (UMLS CUI [2,2])
    C0027651 (UMLS CUI [2,3])
    Uncontrolled hypertension
    Item
    5. uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
    Myocardial Ischemia Stage | Myocardial Infarction Stage | Heart failure
    Item
    6. myocardial ischemia or infarction more than stage ii, cardiac insufficiency.
    boolean
    C0151744 (UMLS CUI [1,1])
    C1306673 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [2,1])
    C1306673 (UMLS CUI [2,2])
    C0018801 (UMLS CUI [3])
    Blood Coagulation Disorders | INR raised | Prothrombin time increased | Prolonged activated partial prothrombin time (aPPT) | Bleeding tendency | Coagulation therapy
    Item
    7. abnormal coagulation (inr>1.5 or pt>uln+4, or aptt>1.5 uln), bleeding tendency or receiving coagulation therapy
    boolean
    C0005779 (UMLS CUI [1])
    C0853225 (UMLS CUI [2])
    C0151872 (UMLS CUI [3])
    C1846819 (UMLS CUI [4])
    C1458140 (UMLS CUI [5])
    C0441509 (UMLS CUI [6])
    Hemoptysis
    Item
    8. hemoptysis, more than 2.5ml daily
    boolean
    C0019079 (UMLS CUI [1])
    Thrombosis | Pulmonary thrombosis | Cerebrovascular accident | Deep Vein Thrombosis
    Item
    9. thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
    boolean
    C0040053 (UMLS CUI [1])
    C0151946 (UMLS CUI [2])
    C0038454 (UMLS CUI [3])
    C0149871 (UMLS CUI [4])
    Bone fracture Non-healed Long-term | Non-healed wound Long-term
    Item
    10. unhealed bone fracture or wound for long time
    boolean
    C0016658 (UMLS CUI [1,1])
    C0205301 (UMLS CUI [1,2])
    C0443252 (UMLS CUI [1,3])
    C0750433 (UMLS CUI [2,1])
    C0443252 (UMLS CUI [2,2])
    Major surgery | Bone fracture | Ulcer
    Item
    11. received big surgery, had bone fracture or ulcer in 4 weeks.
    boolean
    C0679637 (UMLS CUI [1])
    C0016658 (UMLS CUI [2])
    C0041582 (UMLS CUI [3])
    Urinary protein increased | 24 Hour Urine Protein Test
    Item
    12. urine protein≥++, or urine protein in 24 hours≥1.0g
    boolean
    C0858667 (UMLS CUI [1])
    C1254855 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    13. pregnant or lactating woman.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
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