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ID

39941

Beskrivning

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Subject Diary Card form. It has to be filled in at day 2-13, day 15-20 and day 22-27.

Länk

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Nyckelord

Versioner (2)
  1. 2020-03-04 2020-03-04 -
  2. 2020-03-05 2020-03-05 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 mars 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0
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    Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

    Engelsk

    Subject Diary Card

    1 Formulär  
    1. StudyEvent: ODM
      1. Subject Diary Card
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit 3
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Time of Visit 3
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C1320304
    Date of Visit 4
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Time of Visit 4
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C1320304
    In case of emergency, please contact:
    Beskrivning

    In case of emergency, please contact:

    Alias
    UMLS CUI-1
    C0013956
    UMLS CUI-2
    C0332158
    Investigator
    Beskrivning

    Investigator

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Study contact
    Beskrivning

    Study contact

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0332158
    UMLS CUI [1,2]
    C0008976
    Telephone (daytime)
    Beskrivning

    Telephone (daytime)

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1515258
    UMLS CUI [1,2]
    C0332169
    Telephone (evening/weekends)
    Beskrivning

    Telephone (evening/weekends)

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1515258
    UMLS CUI [1,2]
    C0587117
    UMLS CUI [2,1]
    C1515258
    UMLS CUI [2,2]
    C0680190
    Address
    Beskrivning

    Address

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1442065
    Diary card
    Beskrivning

    Diary card

    Alias
    UMLS CUI-1
    C3890583
    Have you registered on the CF Questionnaire website?
    Beskrivning

    Note: Please complete the web based diary (questionnaire) daily in the evenings. Note: Day 1 will be dosed in the unit. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0010674
    UMLS CUI [1,2]
    C3890583
    UMLS CUI [1,3]
    C0159028
    UMLS CUI [1,4]
    C2349146
    UMLS CUI [1,5]
    C1514821
    Study drug
    Beskrivning

    Study drug

    Alias
    UMLS CUI-1
    C0304229
    Dosing day
    Beskrivning

    Note: Do not take bronchodilator prior to clinic visit on Day 14, 21 and 28. Do not perform strenuous exercise 48 hr prior to visit on Day 14, 21 and 28.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0439228
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0304229
    If other dosing day, please specify
    Beskrivning

    Other dosing day

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0439228
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0304229
    Date of Dose
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    Time of Dose
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0040223
    No. of Tablets from Bottle A
    Beskrivning

    e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0039225
    UMLS CUI [1,3]
    C0179376
    No. of Tablets from Bottle B
    Beskrivning

    e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0039225
    UMLS CUI [1,3]
    C0179376
    Exacerbations
    Beskrivning

    Exacerbations

    Alias
    UMLS CUI-1
    C4086268
    Exacerbation event, record
    Beskrivning

    CF Exacerbation event, record.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C4086268
    UMLS CUI [1,2]
    C0010674
    UMLS CUI [1,3]
    C0332127
    Date of Exacerbation Onset
    Beskrivning

    day month year. Note: If you have an exacerbation, immediately contact the site using the details above. Note: Record your individual symptoms in the itemgroup CHANGES IN HEALTH.

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C0010674
    UMLS CUI [1,3]
    C4086268
    Time of Exacerbation Onset
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C0010674
    UMLS CUI [1,3]
    C4086268
    Date of Exacerbation Resolution
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2699488
    UMLS CUI [1,3]
    C0010674
    UMLS CUI [1,4]
    C4086268
    Time of Exacerbation Resolution
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2699488
    UMLS CUI [1,3]
    C0010674
    UMLS CUI [1,4]
    C4086268
    Were antibiotics prescribed for the exacerbation?
    Beskrivning

    If Yes, record each antibiotic in the itemgroup OTHER MEDICATIONS.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0003232
    UMLS CUI [1,2]
    C0033080
    UMLS CUI [1,3]
    C0010674
    UMLS CUI [1,4]
    C4086268
    Did the exacerbation require hospitalization?
    Beskrivning

    Exacerbation of CF requiring hospitalisation

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0010674
    UMLS CUI [1,2]
    C4086268
    UMLS CUI [1,3]
    C1514873
    UMLS CUI [1,4]
    C0019993
    Other medications
    Beskrivning

    Other medications

    Alias
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C0013227
    Medication record
    Beskrivning

    Medication record

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0332127
    Drug Name
    Beskrivning

    e.g., Aspirin

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013227
    Units
    Beskrivning

    e.g., Tablet

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C0013227
    Amount Taken
    Beskrivning

    Amount Taken of medication

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1265611
    UMLS CUI [1,2]
    C0013227
    Reason for medication
    Beskrivning

    e.g., Headache

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Start Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Start Time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1301880
    Stop Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Stop Time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1522314
    Changes in health
    Beskrivning

    Changes in health

    Alias
    UMLS CUI-1
    C0392747
    UMLS CUI-2
    C0018759
    Changes in health, record.
    Beskrivning

    Changes in health, record.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0392747
    UMLS CUI [1,2]
    C0018759
    UMLS CUI [1,3]
    C0332127
    Event
    Beskrivning

    Diagnosis Only (if known) Otherwise Sign/Symptom. e.g., Headache

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0441471
    Start Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C0808070
    Start Time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C1301880
    Stop Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C0806020
    Stop Time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C1522314
    Maximum intensity of event
    Beskrivning

    Maximum intensity of event

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C0518690
    Daily Respiratory Symptom Diary for Cystic Fibrosis
    Beskrivning

    Daily Respiratory Symptom Diary for Cystic Fibrosis

    Alias
    UMLS CUI-1
    C0034394
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0010674
    UMLS CUI-4
    C0332173
    Result of daily Respiratory Symptom Diary for Cystic Fibrosis
    Beskrivning

    This item contains the result of clinical outcome assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [1,3]
    C1457887
    UMLS CUI [1,4]
    C0010674
    UMLS CUI [1,5]
    C0332173
    Tillbaka till toppen

    Similar models

    Subject Diary Card

    1 Formulär
    1. StudyEvent: ODM
      1. Subject Diary Card
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date of Visit 3
    Item
    Date of Visit 3
    date
    C1320303 (UMLS CUI [1])
    Time of Visit 3
    Item
    Time of Visit 3
    time
    C1320304 (UMLS CUI [1])
    Date of Visit 4
    Item
    Date of Visit 4
    date
    C1320303 (UMLS CUI [1])
    Time of Visit 4
    Item
    Time of Visit 4
    time
    C1320304 (UMLS CUI [1])
    Item Group
    In case of emergency, please contact:
    C0013956 (UMLS CUI-1)
    C0332158 (UMLS CUI-2)
    Investigator
    Item
    Investigator
    text
    C2826892 (UMLS CUI [1])
    Study contact
    Item
    Study contact
    text
    C0332158 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Telephone (daytime)
    Item
    Telephone (daytime)
    integer
    C1515258 (UMLS CUI [1,1])
    C0332169 (UMLS CUI [1,2])
    Telephone (evening/weekends)
    Item
    Telephone (evening/weekends)
    integer
    C1515258 (UMLS CUI [1,1])
    C0587117 (UMLS CUI [1,2])
    C1515258 (UMLS CUI [2,1])
    C0680190 (UMLS CUI [2,2])
    Address
    Item
    Address
    text
    C1442065 (UMLS CUI [1])
    Item Group
    Diary card
    C3890583 (UMLS CUI-1)
    Item
    Have you registered on the CF Questionnaire website?
    text
    C0010674 (UMLS CUI [1,1])
    C3890583 (UMLS CUI [1,2])
    C0159028 (UMLS CUI [1,3])
    C2349146 (UMLS CUI [1,4])
    C1514821 (UMLS CUI [1,5])
    Web based cystic fibrosis symptoms diary
    Code List
    Have you registered on the CF Questionnaire website?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Study drug
    C0304229 (UMLS CUI-1)
    Item
    Dosing day
    integer
    C0439228 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Dosing day
    Code List
    Dosing day
    CL Item
    Day 2 (1)
    CL Item
    Day 3 (2)
    CL Item
    Day 4 (3)
    CL Item
    Day 5 (4)
    CL Item
    Day 6 (5)
    CL Item
    Day 7 (6)
    CL Item
    Day 8 (7)
    CL Item
    Day 9 (8)
    CL Item
    Day 10 (9)
    CL Item
    Day 11 (10)
    CL Item
    Day 12 (11)
    CL Item
    Day 13 (12)
    CL Item
    Day 15 (13)
    CL Item
    Day 16 (14)
    CL Item
    Day 17 (15)
    CL Item
    Day 18 (16)
    CL Item
    Day 19 (17)
    CL Item
    Day 20 (18)
    CL Item
    Day 22 (19)
    CL Item
    Day 23 (20)
    CL Item
    Day 24 (21)
    CL Item
    Day 25 (22)
    CL Item
    Day 26 (23)
    CL Item
    Day 27 (24)
    CL Item
    Other (25)
    Other dosing day
    Item
    If other dosing day, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    No. of Tablets from Bottle A
    Item
    No. of Tablets from Bottle A
    integer
    C0237753 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    C0179376 (UMLS CUI [1,3])
    No. of Tablets from Bottle B
    Item
    No. of Tablets from Bottle B
    integer
    C0237753 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    C0179376 (UMLS CUI [1,3])
    Item Group
    Exacerbations
    C4086268 (UMLS CUI-1)
    Item
    Exacerbation event, record
    integer
    C4086268 (UMLS CUI [1,1])
    C0010674 (UMLS CUI [1,2])
    C0332127 (UMLS CUI [1,3])
    CF Exacerbation event, record.
    Code List
    Exacerbation event, record
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    13 (13)
    CL Item
    14 (14)
    CL Item
    15 (15)
    CL Item
    16 (16)
    CL Item
    17 (17)
    CL Item
    18 (18)
    CL Item
    19 (19)
    Date of Exacerbation of CF Onset
    Item
    Date of Exacerbation Onset
    date
    C0574845 (UMLS CUI [1,1])
    C0010674 (UMLS CUI [1,2])
    C4086268 (UMLS CUI [1,3])
    Time of Exacerbation of CF Onset
    Item
    Time of Exacerbation Onset
    time
    C0449244 (UMLS CUI [1,1])
    C0010674 (UMLS CUI [1,2])
    C4086268 (UMLS CUI [1,3])
    Date of Exacerbation of CF Resolution
    Item
    Date of Exacerbation Resolution
    date
    C0011008 (UMLS CUI [1,1])
    C2699488 (UMLS CUI [1,2])
    C0010674 (UMLS CUI [1,3])
    C4086268 (UMLS CUI [1,4])
    Time of Exacerbation of CF Resolution
    Item
    Time of Exacerbation Resolution
    time
    C0040223 (UMLS CUI [1,1])
    C2699488 (UMLS CUI [1,2])
    C0010674 (UMLS CUI [1,3])
    C4086268 (UMLS CUI [1,4])
    Item
    Were antibiotics prescribed for the exacerbation?
    text
    C0003232 (UMLS CUI [1,1])
    C0033080 (UMLS CUI [1,2])
    C0010674 (UMLS CUI [1,3])
    C4086268 (UMLS CUI [1,4])
    Antibiotics prescription for exacerbation of CF
    Code List
    Were antibiotics prescribed for the exacerbation?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Did the exacerbation require hospitalization?
    text
    C0010674 (UMLS CUI [1,1])
    C4086268 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [1,3])
    C0019993 (UMLS CUI [1,4])
    Antibiotics prescription for exacerbation of CF
    Code List
    Did the exacerbation require hospitalization?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Other medications
    C0205394 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    Item
    Medication record
    integer
    C0013227 (UMLS CUI [1,1])
    C0332127 (UMLS CUI [1,2])
    Medication record
    Code List
    Medication record
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    13 (13)
    CL Item
    14 (14)
    CL Item
    15 (15)
    CL Item
    16 (16)
    CL Item
    17 (17)
    CL Item
    18 (18)
    CL Item
    19 (19)
    CL Item
    20 (20)
    CL Item
    21 (21)
    CL Item
    22 (22)
    CL Item
    23 (23)
    CL Item
    24 (24)
    CL Item
    25 (25)
    CL Item
    26 (26)
    CL Item
    27 (27)
    CL Item
    28 (28)
    CL Item
    29 (29)
    CL Item
    30 (30)
    CL Item
    31 (31)
    CL Item
    32 (32)
    CL Item
    33  (33)
    CL Item
    34 (34)
    CL Item
    35 (35)
    CL Item
    36 (36)
    CL Item
    37 (37)
    CL Item
    38 (38)
    CL Item
    39 (39)
    CL Item
    40 (40)
    CL Item
    41 (41)
    CL Item
    42 (42)
    CL Item
    43 (43)
    CL Item
    44 (44)
    CL Item
    45 (45)
    CL Item
    46 (46)
    CL Item
    47 (47)
    CL Item
    48 (48)
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Units of medication
    Item
    Units
    text
    C1519795 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Amount Taken of medication
    Item
    Amount Taken
    integer
    C1265611 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Reason for medication
    Item
    Reason for medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Start Date of medication
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time of medication
    Item
    Start Time
    time
    C0013227 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop Date of medication
    Item
    Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop Time of medication
    Item
    Stop Time
    time
    C0013227 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item Group
    Changes in health
    C0392747 (UMLS CUI-1)
    C0018759 (UMLS CUI-2)
    Item
    Changes in health, record.
    integer
    C0392747 (UMLS CUI [1,1])
    C0018759 (UMLS CUI [1,2])
    C0332127 (UMLS CUI [1,3])
    Changes in health, record.
    Code List
    Changes in health, record.
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    13 (13)
    CL Item
    14 (14)
    CL Item
    15 (15)
    CL Item
    16 (16)
    CL Item
    17 (17)
    CL Item
    18 (18)
    CL Item
    19 (19)
    CL Item
    20 (20)
    CL Item
    21 (21)
    CL Item
    22 (22)
    CL Item
    23 (23)
    CL Item
    24 (24)
    CL Item
    25 (25)
    CL Item
    26 (26)
    CL Item
    27 (27)
    CL Item
    28 (28)
    CL Item
    29 (29)
    CL Item
    30 (30)
    CL Item
    31 (31)
    CL Item
    32 (32)
    CL Item
    33  (33)
    CL Item
    34 (34)
    CL Item
    35 (35)
    CL Item
    36 (36)
    CL Item
    37 (37)
    CL Item
    38 (38)
    CL Item
    39 (39)
    CL Item
    40 (40)
    CL Item
    41 (41)
    CL Item
    42 (42)
    Event
    Item
    Event
    text
    C0441471 (UMLS CUI [1])
    Start Date of event
    Item
    Start Date
    date
    C0441471 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time of event
    Item
    Start Time
    time
    C0441471 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop Date of event
    Item
    Stop Date
    date
    C0441471 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop Time of event
    Item
    Stop Time
    time
    C0441471 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Maximum intensity of event
    integer
    C0441471 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Maximum intensity of event
    Code List
    Maximum intensity of event
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item Group
    Daily Respiratory Symptom Diary for Cystic Fibrosis
    C0034394 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0010674 (UMLS CUI-3)
    C0332173 (UMLS CUI-4)
    Result of daily Respiratory Symptom Diary for Cystic Fibrosis
    Item
    Result of daily Respiratory Symptom Diary for Cystic Fibrosis
    text
    C1274040 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    C0010674 (UMLS CUI [1,4])
    C0332173 (UMLS CUI [1,5])
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