0 Ratings
ID

32337

Description

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the meningitis form. It has to be filled in if a meningitis case occurs during study. It's for all workbooks.

Link

https://clinicaltrials.gov/ct2/show/NCT00466947

Keywords

Versions (1)
  1. 10/27/18 10/27/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 27, 2018

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License

Creative Commons BY-NC 3.0
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    Vaccination against pneumonia and otitis media, NCT00466947

    English

    Meningitis

    1 forms  
    1. StudyEvent: ODM
      1. Meningitis
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Case number
    Description

    Case number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1698493
    UMLS CUI [1,2]
    C0600091
    Workbook number
    Description

    Workbook number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986015
    Date of meningitis case
    Description

    Date of meningitis case

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0025289
    UMLS CUI [1,2]
    C0011008
    SECTION 1: CLINICAL SYMPTOMS
    Description

    SECTION 1: CLINICAL SYMPTOMS

    Alias
    UMLS CUI-1
    C1457887
    Attached to SAE Report N°
    Description

    SAE Report number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0684224
    UMLS CUI [1,3]
    C0237753
    Date of first symptoms
    Description

    Date of first symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0011008
    Signs and Symptoms
    Description

    Please complete for all cases where a meningitis diagnosis is reported.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0037088
    Was the symptom observed/present?
    Description

    Please complete for all cases where a meningitis diagnosis is reported.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1441672
    UMLS CUI [1,2]
    C0037088
    SECTION 2: BLOOD TEST
    Description

    SECTION 2: BLOOD TEST

    Alias
    UMLS CUI-1
    C0018941
    Date of blood test
    Description

    Date of blood test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0011008
    Was antibiotic treatment initiated prior to the blood culture?
    Description

    Antibiotic treatment initiated prior to blood culture

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0338237
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0200949
    Haemogram
    Description

    Haemogram

    Alias
    UMLS CUI-1
    C0200949
    UMLS CUI-2
    C0018941
    White Blood Cell
    Description

    WBC

    Data type

    integer

    Measurement units
    • Cell/ml
    Alias
    UMLS CUI [1]
    C0023508
    Cell/ml
    Granulocytes
    Description

    Granulocytes

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0857490
    %
    Lymphocytes
    Description

    Lymphocytes

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0024264
    %
    Other tests
    Description

    Other tests

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0018941
    Serology
    Description

    Serology

    Alias
    UMLS CUI-1
    C0036743
    UMLS CUI-2
    C0018941
    Serology test: Latex
    Description

    Serology test: Latex

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0023115
    Serology test: Contra immunoelectrophoresis
    Description

    Serology test: Contra immunoelectrophoresis

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201725
    Serology test: Elisa
    Description

    Serology test: Elisa

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0014441
    Other Serology test
    Description

    Please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0036743
    Serology results
    Description

    If there was a positive result please specify in following item

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C1274040
    If positive result: Hib
    Description

    Haemophilus influenzae Type b

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0121772
    If positive result: S. pneumoniae
    Description

    Streptococcus pneumoniae

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0038410
    If positive result: N. meningitidis
    Description

    Neisseria meningitidis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0027575
    If positive result: Streptococcus group B
    Description

    Streptococcus group B

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0579233
    If positive result, other bacteria
    Description

    please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0004611
    Blood culture
    Description

    Blood culture

    Alias
    UMLS CUI-1
    C0200949
    Isolate, Pathogen organism: Staphilococcus aureus
    Description

    Pathogen organism: Staphilococcus aureus

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0450254
    UMLS CUI [1,2]
    C0038172
    Isolate, Pathogen organism: Neisseria meningitidis
    Description

    Pathogen organism: Neisseria meningitidis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0450254
    UMLS CUI [1,2]
    C0027575
    Isolate, Pathogen organism: Streptoccocus pneumoniae
    Description

    Pathogen organism: Streptoccocus pneumoniae

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0450254
    UMLS CUI [1,2]
    C0038410
    Isolate, Pathogen organism: Haemphilus Influenzae type B
    Description

    Pathogen organism: Haemphilus Influenzae type B

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0450254
    UMLS CUI [1,2]
    C0121772
    Pathogen organism, other
    Description

    please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0450254
    UMLS CUI [1,2]
    C0205394
    SECTION 3: LUMBAR PUNCTURE
    Description

    SECTION 3: LUMBAR PUNCTURE

    Alias
    UMLS CUI-1
    C0007806
    Date of lumbar puncture
    Description

    Date of lumbar puncture

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0011008
    Was antibiotic treatment initiated prior to the lumbar puncture?
    Description

    Antibiotic treatment prior lumbar puncture

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0338237
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0007806
    Result: CSF appearance: Clear
    Description

    Result: CSF appearance: Clear

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0007806
    UMLS CUI [1,3]
    C2963144
    Result: CSF appearance: Turbid
    Description

    Result: CSF appearance: Turbid

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0007806
    UMLS CUI [1,3]
    C0311420
    Result: CSF appearance: purulent
    Description

    Result: CSF appearance: purulent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0007806
    UMLS CUI [1,3]
    C0439665
    Result: CSF appearance: Hematic
    Description

    Result: CSF appearance: Hematic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0007806
    UMLS CUI [1,3]
    C0333275
    CSF cell count: Total
    Description

    CSF cell count: Total

    Data type

    float

    Measurement units
    • x 10^6/L
    Alias
    UMLS CUI [1]
    C4063897
    x 10^6/L
    CSF cell count: Polymorphonuclears (PMNs)
    Description

    CSF cell count: Polymorphonuclears (PMNs)

    Data type

    float

    Measurement units
    • x 10^6/L
    Alias
    UMLS CUI [1,1]
    C1168338
    UMLS CUI [1,2]
    C0007806
    x 10^6/L
    CSF cell count: Lymphocytes
    Description

    CSF cell count: Lymphocytes

    Data type

    float

    Measurement units
    • x 10^6/L
    Alias
    UMLS CUI [1,1]
    C0200635
    UMLS CUI [1,2]
    C0007806
    x 10^6/L
    CSF: Protein content
    Description

    CSF: Protein content

    Data type

    float

    Measurement units
    • g/L
    Alias
    UMLS CUI [1,1]
    C0555903
    UMLS CUI [1,2]
    C0007806
    g/L
    CSF: Glucose content
    Description

    Please tick unit of measure in following item

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0337438
    UMLS CUI [1,2]
    C0007806
    Glucose content, CSF
    Description

    Unit of measure, glucose content

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0337438
    UMLS CUI [1,2]
    C0007806
    Plasma glucose concentration
    Description

    Please tick unit of measure in following item

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202042
    Plasma glucose concentration
    Description

    Unit of measure, plasma glucose concentration

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0202042
    % plasma glucose concentration
    Description

    % plasma glucose concentration

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0369269
    %
    Other blood test: Lactate
    Description

    Other blood test: Lactate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0205394
    Other blood test: LDH
    Description

    Other blood test: LDH

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0202113
    Other blood test: ASGOT
    Description

    Other blood test: ASGOT

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0201899
    Other blood test: Creatine phosphokinase
    Description

    Other blood test: Creatine phosphokinase

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0201973
    GRAM stain: positive
    Description

    GRAM stain: positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0061856
    UMLS CUI [1,2]
    C0430402
    UMLS CUI [1,3]
    C1446409
    GRAM stain: negative
    Description

    GRAM stain: negative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0061856
    UMLS CUI [1,2]
    C0430402
    UMLS CUI [1,3]
    C0205160
    GRAM stain: Negative result
    Description

    GRAM stain: Negative result

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0061856
    UMLS CUI [1,2]
    C0430402
    UMLS CUI [1,3]
    C0205160
    UMLS CUI [1,4]
    C1274040
    GRAM stain: Not Done
    Description

    GRAM stain: Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0061856
    UMLS CUI [1,2]
    C0430402
    UMLS CUI [1,3]
    C1272696
    Lumbar puncture: CSF Culture
    Description

    Lumbar puncture: CSF Culture

    Alias
    UMLS CUI-1
    C0007806
    UMLS CUI-2
    C0430400
    CSF Culture, Bacteria
    Description

    If you tick Streptoccocus pneumoniae or Haemophilus influenzae please complete following items

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C0004611
    If other CSF culture please specify
    Description

    Other CSF culture

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0007806
    UMLS CUI [1,3]
    C0430400
    If Streptoccocus pneumoniae please tick Serotype/group
    Description

    Streptoccocus pneumoniae: Serotype/group

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0038410
    UMLS CUI [1,2]
    C0449943
    If other serotype of Streptoccocus pneumoniae please specify
    Description

    Other serotype of Streptoccocus pneumoniae

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0038410
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0449943
    Haemophilus influenzae: Serotype/group
    Description

    Haemophilus influenzae: Serotype/group

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018483
    UMLS CUI [1,2]
    C0449943
    If other serotype of Haemophilus influenzae please specify
    Description

    Other serotype of Haemophilus influenzae

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018483
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0449943
    Lumbar puncture: Antigen detection
    Description

    Lumbar puncture: Antigen detection

    Alias
    UMLS CUI-1
    C0003320
    UMLS CUI-2
    C0007806
    UMLS CUI-3
    C0007806
    Antigen tests
    Description

    Antigen tests

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0729856
    If other antigen test please specify
    Description

    Other antigen test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0729856
    Results: Was there at least one positive result?
    Description

    Positive antigen tests

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0729856
    UMLS CUI [1,2]
    C1446409
    If postive result confirmed please specify
    Description

    Postive result confirmed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0729856
    UMLS CUI [1,2]
    C1446409
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C0750484
    If other positive result please specify
    Description

    Other positive result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0729856
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1446409
    UMLS CUI [1,4]
    C1274040
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    Similar models

    Meningitis

    1 forms
    1. StudyEvent: ODM
      1. Meningitis
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Case number
    Item
    Case number
    integer
    C1698493 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item
    Workbook number
    integer
    C2986015 (UMLS CUI [1])
    Workbook number
    Code List
    Workbook number
    CL Item
    workbook 1 (1)
    CL Item
    workbook 2 (2)
    CL Item
    workbook 3 (3)
    Date of meningitis case
    Item
    Date of meningitis case
    date
    C0025289 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    SECTION 1: CLINICAL SYMPTOMS
    C1457887 (UMLS CUI-1)
    SAE Report number
    Item
    Attached to SAE Report N°
    integer
    C1519255 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Date of first symptoms
    Item
    Date of first symptoms
    date
    C1457887 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Signs and Symptoms
    integer
    C0037088 (UMLS CUI [1])
    Signs and Symptoms
    Code List
    Signs and Symptoms
    CL Item
    Fever (1)
    CL Item
    Stiff neck or positive Kernig's or (2)
    CL Item
    Brudzinski's signs  (3)
    CL Item
    Vomiting (4)
    CL Item
    Photophobia (discomfort from bright light)  (5)
    CL Item
    Sleepiness  (6)
    CL Item
    Seizure  (7)
    CL Item
    Tensing or bulging of fontanel (8)
    CL Item
    Rash  (9)
    CL Item
    Petechia or purpuric rash  (10)
    CL Item
    Refusing to feed  (11)
    CL Item
    Floppy body and lifeless  (12)
    CL Item
    Irritable when picked up, with high pitched or moaning cry (13)
    CL Item
    Confusion (14)
    CL Item
    Nausea (15)
    CL Item
    Headache (16)
    CL Item
    A stiff body with jerky movements (17)
    Item
    Was the symptom observed/present?
    integer
    C1441672 (UMLS CUI [1,1])
    C0037088 (UMLS CUI [1,2])
    Signs and Symptoms
    Code List
    Was the symptom observed/present?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item Group
    SECTION 2: BLOOD TEST
    C0018941 (UMLS CUI-1)
    Date of blood test
    Item
    Date of blood test
    date
    C0018941 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Was antibiotic treatment initiated prior to the blood culture?
    integer
    C0338237 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0200949 (UMLS CUI [1,3])
    Antibiotic treatment initiated prior to blood culture
    Code List
    Was antibiotic treatment initiated prior to the blood culture?
    CL Item
    No (1)
    CL Item
    Yes  (2)
    CL Item
    Unknown (3)
    Item Group
    Haemogram
    C0200949 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    WBC
    Item
    White Blood Cell
    integer
    C0023508 (UMLS CUI [1])
    Granulocytes
    Item
    Granulocytes
    float
    C0857490 (UMLS CUI [1])
    Lymphocytes
    Item
    Lymphocytes
    float
    C0024264 (UMLS CUI [1])
    Other tests
    Item
    Other tests
    text
    C0205394 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    Item Group
    Serology
    C0036743 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    Serology test: Latex
    Item
    Serology test: Latex
    boolean
    C0036743 (UMLS CUI [1,1])
    C0023115 (UMLS CUI [1,2])
    Serology test: Contra immunoelectrophoresis
    Item
    Serology test: Contra immunoelectrophoresis
    integer
    C0036743 (UMLS CUI [1,1])
    C0201725 (UMLS CUI [1,2])
    Serology test: Elisa
    Item
    Serology test: Elisa
    boolean
    C0036743 (UMLS CUI [1,1])
    C0014441 (UMLS CUI [1,2])
    Other Serology test
    Item
    Other Serology test
    text
    C0205394 (UMLS CUI [1,1])
    C0036743 (UMLS CUI [1,2])
    Item
    Serology results
    integer
    C0036743 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Serology results
    Code List
    Serology results
    CL Item
    positive (1)
    CL Item
    negative (2)
    Haemophilus influenzae Type b
    Item
    If positive result: Hib
    boolean
    C0036743 (UMLS CUI [1,1])
    C0121772 (UMLS CUI [1,2])
    Streptococcus pneumoniae
    Item
    If positive result: S. pneumoniae
    boolean
    C0036743 (UMLS CUI [1,1])
    C0038410 (UMLS CUI [1,2])
    Neisseria meningitidis
    Item
    If positive result: N. meningitidis
    boolean
    C0036743 (UMLS CUI [1,1])
    C0027575 (UMLS CUI [1,2])
    Streptococcus group B
    Item
    If positive result: Streptococcus group B
    boolean
    C0036743 (UMLS CUI [1,1])
    C0579233 (UMLS CUI [1,2])
    Other bacteria
    Item
    If positive result, other bacteria
    text
    C0036743 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0004611 (UMLS CUI [1,3])
    Item Group
    Blood culture
    C0200949 (UMLS CUI-1)
    Pathogen organism: Staphilococcus aureus
    Item
    Isolate, Pathogen organism: Staphilococcus aureus
    boolean
    C0450254 (UMLS CUI [1,1])
    C0038172 (UMLS CUI [1,2])
    Pathogen organism: Neisseria meningitidis
    Item
    Isolate, Pathogen organism: Neisseria meningitidis
    boolean
    C0450254 (UMLS CUI [1,1])
    C0027575 (UMLS CUI [1,2])
    Pathogen organism: Streptoccocus pneumoniae
    Item
    Isolate, Pathogen organism: Streptoccocus pneumoniae
    boolean
    C0450254 (UMLS CUI [1,1])
    C0038410 (UMLS CUI [1,2])
    Pathogen organism: Haemphilus Influenzae type B
    Item
    Isolate, Pathogen organism: Haemphilus Influenzae type B
    boolean
    C0450254 (UMLS CUI [1,1])
    C0121772 (UMLS CUI [1,2])
    Pathogen organism, other
    Item
    Pathogen organism, other
    text
    C0450254 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    SECTION 3: LUMBAR PUNCTURE
    C0007806 (UMLS CUI-1)
    Date of lumbar puncture
    Item
    Date of lumbar puncture
    date
    C0007806 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Was antibiotic treatment initiated prior to the lumbar puncture?
    integer
    C0338237 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0007806 (UMLS CUI [1,3])
    Antibiotic treatment prior lumbar puncture
    Code List
    Was antibiotic treatment initiated prior to the lumbar puncture?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Result: CSF appearance: Clear
    Item
    Result: CSF appearance: Clear
    boolean
    C1274040 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    C2963144 (UMLS CUI [1,3])
    Result: CSF appearance: Turbid
    Item
    Result: CSF appearance: Turbid
    boolean
    C1274040 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    C0311420 (UMLS CUI [1,3])
    Result: CSF appearance: purulent
    Item
    Result: CSF appearance: purulent
    boolean
    C1274040 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    C0439665 (UMLS CUI [1,3])
    Result: CSF appearance: Hematic
    Item
    Result: CSF appearance: Hematic
    boolean
    C1274040 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    C0333275 (UMLS CUI [1,3])
    CSF cell count: Total
    Item
    CSF cell count: Total
    float
    C4063897 (UMLS CUI [1])
    CSF cell count: Polymorphonuclears (PMNs)
    Item
    CSF cell count: Polymorphonuclears (PMNs)
    float
    C1168338 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF cell count: Lymphocytes
    Item
    CSF cell count: Lymphocytes
    float
    C0200635 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF: Protein content
    Item
    CSF: Protein content
    float
    C0555903 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF: Glucose content
    Item
    CSF: Glucose content
    boolean
    C0337438 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    Item
    Glucose content, CSF
    integer
    C0337438 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    Unit of measure, glucose content
    Code List
    Glucose content, CSF
    CL Item
    mmol/L (1)
    CL Item
    g/L (2)
    Plasma glucose concentration
    Item
    Plasma glucose concentration
    boolean
    C0202042 (UMLS CUI [1])
    Item
    Plasma glucose concentration
    integer
    C0202042 (UMLS CUI [1])
    Unit of measure, plasma glucose concentration
    Code List
    Plasma glucose concentration
    CL Item
    g/L (1)
    CL Item
    mmol/L (2)
    % plasma glucose concentration
    Item
    % plasma glucose concentration
    float
    C0369269 (UMLS CUI [1])
    Other blood test: Lactate
    Item
    Other blood test: Lactate
    boolean
    C0018941 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other blood test: LDH
    Item
    Other blood test: LDH
    boolean
    C0018941 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0202113 (UMLS CUI [1,3])
    Other blood test: ASGOT
    Item
    Other blood test: ASGOT
    boolean
    C0018941 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0201899 (UMLS CUI [1,3])
    Other blood test: Creatine phosphokinase
    Item
    Other blood test: Creatine phosphokinase
    boolean
    C0018941 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0201973 (UMLS CUI [1,3])
    GRAM stain: positive
    Item
    GRAM stain: positive
    boolean
    C0061856 (UMLS CUI [1,1])
    C0430402 (UMLS CUI [1,2])
    C1446409 (UMLS CUI [1,3])
    GRAM stain: negative
    Item
    GRAM stain: negative
    boolean
    C0061856 (UMLS CUI [1,1])
    C0430402 (UMLS CUI [1,2])
    C0205160 (UMLS CUI [1,3])
    GRAM stain: Negative result
    Item
    GRAM stain: Negative result
    boolean
    C0061856 (UMLS CUI [1,1])
    C0430402 (UMLS CUI [1,2])
    C0205160 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    GRAM stain: Not Done
    Item
    GRAM stain: Not Done
    boolean
    C0061856 (UMLS CUI [1,1])
    C0430402 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item Group
    Lumbar puncture: CSF Culture
    C0007806 (UMLS CUI-1)
    C0430400 (UMLS CUI-2)
    Item
    CSF Culture, Bacteria
    integer
    C0007806 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C0004611 (UMLS CUI [1,3])
    CSF Culture
    Code List
    CSF Culture, Bacteria
    CL Item
    Staphilococcus aureus (1)
    CL Item
    Neisseria meningitidis (2)
    CL Item
    Streptoccocus pneumoniae (3)
    CL Item
    Haemophilus influenzae (4)
    CL Item
    other (5)
    Other CSF culture
    Item
    If other CSF culture please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    C0430400 (UMLS CUI [1,3])
    Item
    If Streptoccocus pneumoniae please tick Serotype/group
    integer
    C0038410 (UMLS CUI [1,1])
    C0449943 (UMLS CUI [1,2])
    Streptoccocus pneumoniae: Serotype/group
    Code List
    If Streptoccocus pneumoniae please tick Serotype/group
    CL Item
    1  (1)
    CL Item
    4  (2)
    CL Item
    5  (3)
    CL Item
    6A  (4)
    CL Item
    6B (5)
    CL Item
    7F  (6)
    CL Item
    9V  (7)
    CL Item
    14  (8)
    CL Item
    18C  (9)
    CL Item
    19A (10)
    CL Item
    19F  (11)
    CL Item
    23F  (12)
    CL Item
    Other (13)
    CL Item
    Unknown (14)
    Other serotype of Streptoccocus pneumoniae
    Item
    If other serotype of Streptoccocus pneumoniae please specify
    text
    C0038410 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0449943 (UMLS CUI [1,3])
    Item
    Haemophilus influenzae: Serotype/group
    integer
    C0018483 (UMLS CUI [1,1])
    C0449943 (UMLS CUI [1,2])
    Haemophilus influenzae: Serotype/group
    Code List
    Haemophilus influenzae: Serotype/group
    CL Item
    a  (1)
    CL Item
    b  (2)
    CL Item
    c  (3)
    CL Item
    d  (4)
    CL Item
    e (5)
    CL Item
    f  (6)
    CL Item
    Other (7)
    Other serotype of Haemophilus influenzae
    Item
    If other serotype of Haemophilus influenzae please specify
    text
    C0018483 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0449943 (UMLS CUI [1,3])
    Item Group
    Lumbar puncture: Antigen detection
    C0003320 (UMLS CUI-1)
    C0007806 (UMLS CUI-2)
    C0007806 (UMLS CUI-3)
    Item
    Antigen tests
    integer
    C0729856 (UMLS CUI [1])
    Antigen tests
    Code List
    Antigen tests
    CL Item
    Binax Now (1)
    CL Item
    Contra immunoelectrofloresis (2)
    CL Item
    Elisa (3)
    CL Item
    Latex (4)
    CL Item
    PCR (5)
    CL Item
    Other (6)
    Other antigen test
    Item
    If other antigen test please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0729856 (UMLS CUI [1,2])
    Positive antigen tests
    Item
    Results: Was there at least one positive result?
    boolean
    C0729856 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    Item
    If postive result confirmed please specify
    integer
    C0729856 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C0750484 (UMLS CUI [1,4])
    Postive result confirmed
    Code List
    If postive result confirmed please specify
    CL Item
    Hib (1)
    CL Item
    S.pneumoniae (2)
    CL Item
    N. Meningitidis (3)
    CL Item
    Streptoccocus group B (4)
    CL Item
    Other (5)
    Other positive result
    Item
    If other positive result please specify
    text
    C0729856 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1446409 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
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