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36119

Description

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains Diary card form. It has to be filled in of subject.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

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April 15, 2019

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License

Creative Commons BY-NC 3.0
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    Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318

    English

    Diary card

    1 forms  
    1. StudyEvent: ODM
      1. Diary card
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Dose type
    Description

    Dose type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0332307
    Workbook Number
    Description

    6/10/14 weeks schedule for WB1 2/4/6 months schedule for WB 2

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986015
    Please do not forget to bring back the diary card on:
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0332156
    UMLS CUI [1,3]
    C0011008
    In case of hospitalization, please inform
    Description

    Contact person, Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0337611
    UMLS CUI [1,2]
    C1547383
    Contact person, Telephone number
    Description

    Contact person, Telephone number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0337611
    UMLS CUI [1,2]
    C1515258
    Local symptoms (at injection sites)
    Description

    Local symptoms (at injection sites)

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0205276
    Vaccine
    Description

    for investigator only: Could you please check the appropriate box (side / site) for assessment. IPV Vaccine: Fill in only for Workbook 2.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042210
    Vaccine administration, Side
    Description

    for investigator only: Could you please check the appropriate box (side / site) for assessment.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Vaccine administration, Site
    Description

    for investigator only: Could you please check the appropriate box (side / site) for assessment. Upper and Lower thigh only options for DTPw-HBV/Hib Vaccine and IPC Vaccine.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0013153
    UMLS CUI [1,3]
    C0042210
    Local symptoms
    Description

    Local symptoms

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0205276
    UMLS CUI [1,3]
    C2700396
    Day after Vaccination
    Description

    For Day 1-3: note in the evening. Please give information for each symptom and day mentioned.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0205276
    UMLS CUI [1,3]
    C1457887
    UMLS CUI [1,4]
    C0332282
    UMLS CUI [1,5]
    C0042196
    Size of local symptom
    Description

    Please measure the greatest diameter (in mm). Fulfill for Redness and swelling.

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0205276
    UMLS CUI [1,3]
    C0456389
    mm
    Intensity of Pain
    Description

    Definition: 0: Absent 1: Minor reaction to touch 2: Cries/protests on touch 3: Cries when limb is moved / spontaneously painful

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0030193
    Ongoing after Day 3?
    Description

    Local symptom ongoing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0205276
    UMLS CUI [1,3]
    C0549178
    If symptom is ongoing after Day 3, please specify the date of the last day of symptom
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C1457887
    Medically attended Visit
    Description

    Medically attended Visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1518404
    Other local symptoms
    Description

    Other local symptoms

    Alias
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0205276
    Other local symptoms, Description - please specify side(s) and site(s)
    Description

    Other local symptoms, description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0205276
    UMLS CUI [2,1]
    C0441987
    UMLS CUI [2,2]
    C1457887
    UMLS CUI [2,3]
    C0205276
    UMLS CUI [3,1]
    C1515974
    UMLS CUI [3,2]
    C1457887
    UMLS CUI [3,3]
    C0205276
    Other local symptoms, Intensity
    Description

    Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0205276
    UMLS CUI [2]
    C0518690
    Start date of other local symptom
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1457887
    UMLS CUI [1,4]
    C0205276
    End date of other local symptom
    Description

    day month year. or check box below, if continuing.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1457887
    UMLS CUI [1,4]
    C0205276
    Check if other local symptom continuing
    Description

    Other local symptom ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0205276
    UMLS CUI [1,3]
    C1457887
    UMLS CUI [1,4]
    C0549178
    Medically attended Visit
    Description

    Medically attended Visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1518404
    General Symptoms
    Description

    General Symptoms

    Alias
    UMLS CUI-1
    C0159028
    General symptom
    Description

    General symptom

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0159028
    Day after Vaccination
    Description

    For Day 1-3: note in the evening. Please give information for each symptom and day mentioned.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0332282
    UMLS CUI [1,4]
    C0042196
    If "Temperature", please note the route of measurement.
    Description

    Body temperature, route of measurement

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0449444
    Body temperature
    Description

    Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value for the day.

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Intensity of symptom
    Description

    Definition: Irritability / fussiness: 0: Behavior as usual 1: Crying more than usual / no effect on normal activity 2: Crying more than usual / interferes with normal activity 3: Crying that cannot be comforted / prevents normal activity Drowsiness: 0:Behavior as usual 1:Drowsiness easily tolerated 2:Drowsiness that interferes with normal activity 3:Drowsiness that prevents normal activity Loss of appetite: 0: Appetite as usual 1: Eating less than usual / no effect on normal activity 2: Eating less than usual / interferes with normal activity 3: Not eating at all

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Ongoing after Day 3?
    Description

    General symptom ongoing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0159028
    UMLS CUI [1,2]
    C0549178
    If symptom is ongoing after Day 3, please specify the date of the last day of symptom
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C1457887
    Medically attended Visit
    Description

    Medically attended Visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1518404
    Other general symptoms
    Description

    Other general symptoms

    Alias
    UMLS CUI-1
    C0029625
    Other local symptoms, Description - please specify side(s) and site(s)
    Description

    Other local symptoms, description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0205276
    UMLS CUI [2,1]
    C0441987
    UMLS CUI [2,2]
    C0678257
    UMLS CUI [3,1]
    C1515974
    UMLS CUI [3,2]
    C0678257
    Other local symptoms, Intensity
    Description

    Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0205276
    UMLS CUI [2]
    C0518690
    Start date of general symptom
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0159028
    End date of general symptom
    Description

    day month year. or check box below, if continuing.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0159028
    Check if other general symptom continuing
    Description

    Other general symptom ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0159028
    UMLS CUI [1,3]
    C0549178
    Medically attended Visit
    Description

    Medically attended Visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1518404
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Trade / Generic Name of medication
    Description

    Trade / Generic Name of medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C0013227
    Reason for medication
    Description

    Indication of medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Total daily dose
    Description

    Total daily dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826638
    Start date of medication
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End date of medication
    Description

    day month year. or check box below, if continuing.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Check if medication continuing
    Description

    Medication ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
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    Similar models

    Diary card

    1 forms
    1. StudyEvent: ODM
      1. Diary card
    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])
    Item
    Dose type
    integer
    C3174092 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Dose type
    Code List
    Dose type
    CL Item
    Dose 1 (1)
    CL Item
    Dose 2 (2)
    CL Item
    Dose 3 (3)
    Item
    Workbook Number
    integer
    C2986015 (UMLS CUI [1])
    Workbook Number
    Code List
    Workbook Number
    CL Item
    WB 1 (1)
    CL Item
    WB 2 (2)
    Date of diary card return
    Item
    Please do not forget to bring back the diary card on:
    date
    C3890583 (UMLS CUI [1,1])
    C0332156 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Contact person, Name
    Item
    In case of hospitalization, please inform
    text
    C0337611 (UMLS CUI [1,1])
    C1547383 (UMLS CUI [1,2])
    Contact person, Telephone number
    Item
    Contact person, Telephone number
    integer
    C0337611 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    Item Group
    Local symptoms (at injection sites)
    C1457887 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    Item
    Vaccine
    integer
    C0042210 (UMLS CUI [1])
    Vaccine
    Code List
    Vaccine
    CL Item
    10Pn-PD-DiT or Prevenar Vaccine (1)
    CL Item
    DTPw-HBV/Hib Vaccine (2)
    CL Item
    IPV Vaccine (3)
    Item
    Vaccine administration, Side
    text
    C0441987 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Vaccine
    Code List
    Vaccine administration, Side
    CL Item
    Left (L)
    CL Item
    Right (R)
    Item
    Vaccine administration, Site
    integer
    C1515974 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Vaccine
    Code List
    Vaccine administration, Site
    CL Item
    Arm (1)
    CL Item
    Thigh (2)
    CL Item
    Upper thigh (3)
    CL Item
    Lower thigh (4)
    CL Item
    Buttock (5)
    Item
    Local symptoms
    text
    C1457887 (UMLS CUI [1,1])
    C0205276 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Local symptoms
    Code List
    Local symptoms
    CL Item
    Redness (RE)
    CL Item
    Swelling (SW)
    CL Item
    Pain (P)
    Item
    Day after Vaccination
    integer
    C0439228 (UMLS CUI [1,1])
    C0205276 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    C0332282 (UMLS CUI [1,4])
    C0042196 (UMLS CUI [1,5])
    Day after Vaccination
    Code List
    Day after Vaccination
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2  (3)
    CL Item
    Day 3  (4)
    Size of local symptom
    Item
    Size of local symptom
    integer
    C1457887 (UMLS CUI [1,1])
    C0205276 (UMLS CUI [1,2])
    C0456389 (UMLS CUI [1,3])
    Item
    Intensity of Pain
    integer
    C0518690 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    Intensity of Pain
    Code List
    Intensity of Pain
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    Item
    Ongoing after Day 3?
    text
    C1457887 (UMLS CUI [1,1])
    C0205276 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    Local symptom ongoing
    Code List
    Ongoing after Day 3?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Date of last Day of Symptoms
    Item
    If symptom is ongoing after Day 3, please specify the date of the last day of symptom
    date
    C0011008 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    Item
    Medically attended Visit
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Medically attended Visit
    Code List
    Medically attended Visit
    CL Item
    Yes  (Y)
    CL Item
    No (N)
    Item Group
    Other local symptoms
    C0205394 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    Other local symptoms, description
    Item
    Other local symptoms, Description - please specify side(s) and site(s)
    text
    C0205394 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    C0441987 (UMLS CUI [2,1])
    C1457887 (UMLS CUI [2,2])
    C0205276 (UMLS CUI [2,3])
    C1515974 (UMLS CUI [3,1])
    C1457887 (UMLS CUI [3,2])
    C0205276 (UMLS CUI [3,3])
    Item
    Other local symptoms, Intensity
    integer
    C0205394 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    C0518690 (UMLS CUI [2])
    Other local symptoms, Intensity
    Code List
    Other local symptoms, Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Start date of other local symptom
    Item
    Start date of other local symptom
    date
    C0808070 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    C0205276 (UMLS CUI [1,4])
    End date of other local symptom
    Item
    End date of other local symptom
    date
    C0806020 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    C0205276 (UMLS CUI [1,4])
    Other local symptom ongoing
    Item
    Check if other local symptom continuing
    boolean
    C0205394 (UMLS CUI [1,1])
    C0205276 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    C0549178 (UMLS CUI [1,4])
    Item
    Medically attended Visit
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Medically attended Visit
    Code List
    Medically attended Visit
    CL Item
    Yes  (Y)
    CL Item
    No (N)
    Item Group
    General Symptoms
    C0159028 (UMLS CUI-1)
    Item
    General symptom
    integer
    C0159028 (UMLS CUI [1])
    General symptom
    Code List
    General symptom
    CL Item
    Temperature (1)
    CL Item
    Irritability/Fussiness (2)
    CL Item
    Drowsiness (3)
    CL Item
    Loss of appetite (4)
    Item
    Day after Vaccination
    integer
    C0439228 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0332282 (UMLS CUI [1,3])
    C0042196 (UMLS CUI [1,4])
    Day after Vaccination
    Code List
    Day after Vaccination
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2  (3)
    CL Item
    Day 3  (4)
    Item
    If "Temperature", please note the route of measurement.
    integer
    C0886414 (UMLS CUI [1,1])
    C0449444 (UMLS CUI [1,2])
    Body temperature, route of measurement
    Code List
    If "Temperature", please note the route of measurement.
    CL Item
    Axillary (1)
    CL Item
    Oral (2)
    CL Item
    Tymp (oral setting) (3)
    CL Item
    Tymp (rectal setting) (4)
    CL Item
    Rectal (5)
    Body temperature
    Item
    Body temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Intensity of symptom
    integer
    C0518690 (UMLS CUI [1])
    Intensity of symptom
    Code List
    Intensity of symptom
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    Item
    Ongoing after Day 3?
    text
    C0159028 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    General symptom ongoing
    Code List
    Ongoing after Day 3?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of last Day of Symptoms
    Item
    If symptom is ongoing after Day 3, please specify the date of the last day of symptom
    date
    C0011008 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    Item
    Medically attended Visit
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Medically attended Visit
    Code List
    Medically attended Visit
    CL Item
    Yes  (Y)
    CL Item
    No (N)
    Item Group
    Other general symptoms
    C0029625 (UMLS CUI-1)
    Other local symptoms, description
    Item
    Other local symptoms, Description - please specify side(s) and site(s)
    text
    C0205394 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    C0441987 (UMLS CUI [2,1])
    C0678257 (UMLS CUI [2,2])
    C1515974 (UMLS CUI [3,1])
    C0678257 (UMLS CUI [3,2])
    Item
    Other local symptoms, Intensity
    integer
    C0205394 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    C0518690 (UMLS CUI [2])
    Other local symptoms, Intensity
    Code List
    Other local symptoms, Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Start date of general symptom
    Item
    Start date of general symptom
    date
    C0808070 (UMLS CUI [1,1])
    C0159028 (UMLS CUI [1,2])
    End date of general symptom
    Item
    End date of general symptom
    date
    C0806020 (UMLS CUI [1,1])
    C0159028 (UMLS CUI [1,2])
    Other general symptom ongoing
    Item
    Check if other general symptom continuing
    boolean
    C0205394 (UMLS CUI [1,1])
    C0159028 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    Item
    Medically attended Visit
    text
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Medically attended Visit
    Code List
    Medically attended Visit
    CL Item
    Yes  (Y)
    CL Item
    No (N)
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Trade / Generic Name of medication
    Item
    Trade / Generic Name of medication
    text
    C2360065 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Indication of medication
    Item
    Reason for medication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Total daily dose
    Item
    Total daily dose
    text
    C2826638 (UMLS CUI [1])
    Start date of medication
    Item
    Start date of medication
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End date of medication
    Item
    End date of medication
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication ongoing
    Item
    Check if medication continuing
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
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