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ID

44900

Beschrijving

Sponsor: OSI Pharmaceuticals Information provided by : Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Baseline Local Laboratory Data

Link

https://clinicaltrials.gov/ct2/show/NCT00373425

Trefwoorden

  1. 01-08-16 01-08-16 -
  2. 27-09-16 27-09-16 -
  3. 01-04-22 01-04-22 - Martin Dugas
  4. 01-04-22 01-04-22 - Martin Dugas
Houder van rechten

Astellas Pharma Inc

Geüploaded op

1 april 2022

DOI

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Licentie

Creative Commons BY-NC 4.0

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    Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

    Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    1. StudyEvent: Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425
      1. Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
    Hematology
    Beschrijving

    Hematology

    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0011008
    Lab Name
    Beschrijving

    For each different lab, provide normal ranges.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1882331
    Hemoglobin
    Beschrijving

    Hemoglobin

    Datatype

    float

    Maateenheden
    • g/dl
    Alias
    UMLS CUI [1]
    C0518015
    g/dl
    WBC
    Beschrijving

    WBC

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0023508
    ANC
    Beschrijving

    Neutrophil count

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0200633
    Platelet Count
    Beschrijving

    Platelet Count

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0032181
    Biochemistry
    Beschrijving

    Biochemistry

    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0011008
    Lab Name
    Beschrijving

    For each different lab, provide normal ranges.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1882331
    Creatinine
    Beschrijving

    Creatinine

    Datatype

    float

    Maateenheden
    • mg/dl
    Alias
    UMLS CUI [1]
    C0201976
    mg/dl
    Total Bilirubin
    Beschrijving

    Total Bilirubin

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201913
    ALT (SGPT)
    Beschrijving

    ALT

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0201836
    Sodium
    Beschrijving

    Sodium

    Datatype

    float

    Maateenheden
    • mmol/l
    Alias
    UMLS CUI [1]
    C0337443
    mmol/l
    Potassium
    Beschrijving

    Potassium

    Datatype

    float

    Maateenheden
    • mmol/l
    Alias
    UMLS CUI [1]
    C0202194
    mmol/l
    Magnesium
    Beschrijving

    Magnesium

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0373675
    Pregnancy Tests
    Beschrijving

    Pregnancy Tests

    Pregnancy Test: Not Applicable
    Beschrijving

    Pregnancy Test

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    Was a serum pregnancy test performed?
    Beschrijving

    Pregnancy Tests

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    If Yes, date test performed:
    Beschrijving

    Pregnancy test date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy test result
    Beschrijving

    If positive, complete an Initial Pregnancy Report form.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0427777

    Similar models

    Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    1. StudyEvent: Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425
      1. Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Hematology
    Date
    Item
    Date
    date
    C0022885 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory Name
    Item
    Lab Name
    text
    C1882331 (UMLS CUI [1])
    Hemoglobin
    Item
    Hemoglobin
    float
    C0518015 (UMLS CUI [1])
    WBC
    Item
    WBC
    float
    C0023508 (UMLS CUI [1])
    Neutrophil count
    Item
    ANC
    float
    C0200633 (UMLS CUI [1])
    Platelet Count
    Item
    Platelet Count
    float
    C0032181 (UMLS CUI [1])
    Item Group
    Biochemistry
    Date
    Item
    Date
    date
    C0022885 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory Name
    Item
    Lab Name
    text
    C1882331 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    Total Bilirubin
    Item
    Total Bilirubin
    float
    C0201913 (UMLS CUI [1])
    ALT
    Item
    ALT (SGPT)
    float
    C0201836 (UMLS CUI [1])
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Magnesium
    Item
    Magnesium
    float
    C0373675 (UMLS CUI [1])
    Item Group
    Pregnancy Tests
    Pregnancy Test
    Item
    Pregnancy Test: Not Applicable
    boolean
    C0032976 (UMLS CUI [1])
    Pregnancy Tests
    Item
    Was a serum pregnancy test performed?
    boolean
    C0032976 (UMLS CUI [1])
    Pregnancy test date
    Item
    If Yes, date test performed:
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy test result
    integer
    C0427777 (UMLS CUI [1])
    Code List
    Pregnancy test result
    CL Item
    Positive (1)
    CL Item
    Negative (2)

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