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ID

39922

Description

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 concomitant medication form. It has to be filled in if concomitant medication has been taken by subject during the study.

Link

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

Keywords

Versions (2)
  1. 2/25/20 2/25/20 -
  2. 3/4/20 3/4/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 2020

DOI

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License

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

    English

    Concomitant medication

    1 forms  
    1. StudyEvent: ODM
      1. Concomitant medication
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Sequence Number
    Description

    Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348184 (Sequence Number)
    Drug Name
    Description

    (Trade Name preferred)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Modified reported term
    Description

    In the original form this item is hidden.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819 (Concomitant Medication Modified Reported Term)
    GSK Drug synonym
    Description

    In the original form this item is hidden.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0871468 (Synonym)
    GSK Drug Collection code
    Description

    In the original form this item is hidden.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C1516698 (Collection (action))
    LOINC
    LP20988-9
    UMLS CUI [1,3]
    C0805701 (Code)
    Failed coding
    Description

    In the original form this item is hidden.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0805701 (Code)
    UMLS CUI [1,2]
    C0231175 (Failed)
    Unit Dose
    Description

    Unit Dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0869039 (Unit dose)
    SNOMED
    408102007
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Units of concomitant medication
    Description

    Units of concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Frequency of concomitant medication
    Description

    Frequency of concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826654 (Concomitant Medication Dose Frequency)
    Route of concomitant medication
    Description

    Route of concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826730 (Concomitant Medication Route of Administration)
    Reason for Medication
    Description

    Reason for Medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696 (Concomitant Medication Use Indication)
    Start Date of concomitant medication
    Description

    day month year

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Start Time of concomitant medication
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Taken Prior to Study?
    Description

    Concomitant medication prior to study

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Concomitant medication Ongoing?
    Description

    If you tick No, please specify End date and time in the appropriate items.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    End Date of concomitant medication
    Description

    day month year

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    End Time of concomitant medication
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314 (End Time)
    SNOMED
    397898000
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
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    Similar models

    Concomitant medication

    1 forms
    1. StudyEvent: ODM
      1. Concomitant medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Sequence Number
    Item
    Sequence Number
    integer
    C2348184 (UMLS CUI [1])
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Modified reported term
    Item
    Modified reported term
    text
    C2826819 (UMLS CUI [1])
    GSK Drug synonym
    Item
    GSK Drug synonym
    text
    C0013227 (UMLS CUI [1,1])
    C0871468 (UMLS CUI [1,2])
    GSK Drug Collection code
    Item
    GSK Drug Collection code
    text
    C0013227 (UMLS CUI [1,1])
    C1516698 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Failed coding
    Item
    Failed coding
    text
    C0805701 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Unit Dose
    Item
    Unit Dose
    text
    C0869039 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item
    Units of concomitant medication
    text
    C1519795 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Units of concomitant medication
    Code List
    Units of concomitant medication
    CL Item
    Actuation  (ACTU)
    CL Item
    Ampoule  (AMP)
    CL Item
    Application  (APP)
    CL Item
    Area under curve  (AUC)
    CL Item
    Bottle (BOT)
    CL Item
    Capsule  (CAP)
    CL Item
    Cubic centimeter  (CC)
    CL Item
    Cup  (CUP)
    CL Item
    Gamma per kilogram per minute  (GA/KG/MIN)
    CL Item
    Gram  (G)
    CL Item
    Drops  (GTT)
    CL Item
    100 International units/ml (100IU/ML)
    CL Item
    Inhalation (INH)
    CL Item
    International units (IU)
    CL Item
    International units per kilogram  (IU/KG)
    CL Item
    International units per kilogram per hour  (IU/KG/HR)
    CL Item
    International units per millilitre  (IU/ML)
    CL Item
    Litre (L)
    CL Item
    Lozenge  (LOZ)
    CL Item
    Litre per minute  (L/MIN)
    CL Item
    Minimum alveolar concentration  (MAC)
    CL Item
    Mega becquerels (MBq)  (MBQ)
    CL Item
    Microgram (MCG)  (MCG)
    CL Item
    Micrograms per hour  (MCG/HR)
    CL Item
    Microgram/kilogram  (MCG/KG)
    CL Item
    Microgram/kilogram per minute  (MCG/KG/MIN)
    CL Item
    Micrograms per minute  (MCG/MIN)
    CL Item
    Micrograms per minute  (MCG/MIN)
    CL Item
    Micrograms per millitre  (MCG/ML)
    CL Item
    Microlitre  (MCL)
    CL Item
    Milliequivalent  (MEQ)
    CL Item
    Milliequivalent per 24 hours  (MEQ/24HR)
    CL Item
    Milligram  (MG)
    CL Item
    Milligram per day  (MG/DAY)
    CL Item
    Milligram per hour  (MG/HR)
    CL Item
    Milligram/kilogram  (MG/KG)
    CL Item
    Milligram/kilogram per hour  (MG/KG/HR)
    CL Item
    Milligram/kilogram per minute  (MG/KG/MIN)
    CL Item
    Milligram/metre squared  (MG/M2)
    CL Item
    Milligram/millilitre  (MG/ML)
    CL Item
    Milligrams percent  (MG%)
    CL Item
    Million international units  (MIU)
    CL Item
    Millilitre  (ML)
    CL Item
    Millilitre per hour  (ML/HR)
    CL Item
    Millilitre per minute  (ML/MIN)
    CL Item
    Millimole  (MMOL)
    CL Item
    Megaunits (million units)  (MU)
    CL Item
    Nebule  (NEB)
    CL Item
    Ounce  (OZ)
    CL Item
    Patch  (PATCH)
    CL Item
    Percent  (%)
    CL Item
    Puff  (PUFF)
    CL Item
    Sachet  (SACH)
    CL Item
    Spray  (SPR)
    CL Item
    Suppository  (SUPP)
    CL Item
    Tablet  (TAB)
    CL Item
    Tablespoon  (TBLSP)
    CL Item
    Teaspoon  (TSP)
    CL Item
    Microgram (UG)  (UG)
    CL Item
    Units per hour  (U/HR)
    CL Item
    Units per kilogram per minute  (U/KG/MIN)
    CL Item
    Units per minute  (U/MIN)
    CL Item
    Units  (U)
    CL Item
    Unknown  (UNK)
    CL Item
    Vial  (VIAL)
    Item
    Frequency of concomitant medication
    text
    C2826654 (UMLS CUI [1])
    Units of concomitant medication
    Code List
    Frequency of concomitant medication
    CL Item
    2 times per week  (2XWK)
    CL Item
    3 times per week  (3XWK)
    CL Item
    4 times per week  (4XWK)
    CL Item
    5 times per day  (5XD)
    CL Item
    5 times per week  (5XWK)
    CL Item
    AC (AC)
    CL Item
    BID (BID)
    CL Item
    Continuous infusion (CINF)
    CL Item
    HS (HS)
    CL Item
    Once daily (OD)
    CL Item
    Once only (ONE)
    CL Item
    PC (PC)
    CL Item
    PRN (PRN)
    CL Item
    Q12H (Q12H)
    CL Item
    Q2H (Q2H)
    CL Item
    Every 2 weeks (Q2WK)
    CL Item
    Q3D (Q3D)
    CL Item
    Every 3 months (Q3M)
    CL Item
    Every 3 weeks (Q3WK)
    CL Item
    Q4D (Q4D)
    CL Item
    Q4H (Q4H)
    CL Item
    Q6H (Q6H)
    CL Item
    Q8H (Q8H)
    CL Item
    QAM (QAM)
    CL Item
    QH (QH)
    CL Item
    QID (QID)
    CL Item
    Once a month (QM)
    CL Item
    Every other day (QOD)
    CL Item
    QPM (QPM)
    CL Item
    Once a week (QWK)
    CL Item
    TID (TID)
    CL Item
    Unknown (UNK)
    CL Item
    With meals (Meals)
    CL Item
    With snacks (Snacks)
    Item
    Route of concomitant medication
    text
    C2826730 (UMLS CUI [1])
    Route of concomitant medication
    Code List
    Route of concomitant medication
    CL Item
    Epidural  (EP)
    CL Item
    Gastrostomy tube  (GTT)
    CL Item
    Intra-arterial  (IA)
    CL Item
    Intra-articular  (IART)
    CL Item
    Intra-bursa  (IB)
    CL Item
    Intradermal  (ID)
    CL Item
    Inhalation  (IH)
    CL Item
    Intralesional  (ILES)
    CL Item
    Intramuscular  (IM)
    CL Item
    Intranasal  (IN)
    CL Item
    Injection  (INJ)
    CL Item
    Intraocular  (IO)
    CL Item
    Intraosteal  (IOS)
    CL Item
    Intraperitoneal  (IP)
    CL Item
    Intrathecal (IT)
    CL Item
    Intrauterine  (IU)
    CL Item
    Intravenous  (IV)
    CL Item
    Nasogastric  (NG)
    CL Item
    Nasal  (NS)
    CL Item
    Right eye  (OD)
    CL Item
    Ophthalmic  (OP)
    CL Item
    Left eye  (OS)
    CL Item
    Otic  (OT)
    CL Item
    Other  (OTH)
    CL Item
    Both eyes  (OU)
    CL Item
    Oral  (PO)
    CL Item
    Rectal  (PR)
    CL Item
    Subcutaneous  (SC)
    CL Item
    Sublingual  (SL)
    CL Item
    Transdermal  (TD)
    CL Item
    Topical  (TP)
    CL Item
    Unknown  (UNK)
    CL Item
    Vaginal  (VG)
    Reason for Medication
    Item
    Reason for Medication
    text
    C2826696 (UMLS CUI [1])
    Start Date of concomitant medication
    Item
    Start Date of concomitant medication
    partialDate
    C2826734 (UMLS CUI [1])
    Start Time of concomitant medication
    Item
    Start Time of concomitant medication
    time
    C2347852 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Item
    Taken Prior to Study?
    text
    C2826667 (UMLS CUI [1])
    Concomitant medication prior to study
    Code List
    Taken Prior to Study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Concomitant medication Ongoing?
    text
    C2826666 (UMLS CUI [1])
    Concomitant medication Ongoing
    Code List
    Concomitant medication Ongoing?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    End Date of concomitant medication
    Item
    End Date of concomitant medication
    partialDate
    C2826744 (UMLS CUI [1])
    End Time of concomitant medication
    Item
    End Time of concomitant medication
    time
    C1522314 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
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