0 Beoordelingen

ID

41527

Beschrijving

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (COPD and concomitant medication) is to be filled out continuously during the study whenever applicable.

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Trefwoorden

  1. 01-11-20 01-11-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 november 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

    COPD and concomitant medication

    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject identification number
    Beschrijving

    Subject identification number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit/assessment
    Beschrijving

    Date of visit/assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    COPD Prior concomitant medications
    Beschrijving

    COPD Prior concomitant medications

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    UMLS CUI-3
    C0024117
    Sequence number
    Beschrijving

    [hidden]

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2348184
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2826257
    UMLS CUI [1,4]
    C0024117
    Drug name
    Beschrijving

    (Trade Name preferred)

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2826257
    UMLS CUI [1,4]
    C0024117
    Modified reported term
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826819
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C0024117
    GSK Drug synonym
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826819
    UMLS CUI [1,2]
    C0871468
    UMLS CUI [1,3]
    C2826257
    UMLS CUI [1,4]
    C0024117
    GSK Drug Collection code
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C0024117
    UMLS CUI [1,4]
    C1516698
    UMLS CUI [1,5]
    C0805701
    Failed coding
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C0024117
    UMLS CUI [1,4]
    C0805701
    UMLS CUI [1,5]
    C0231175
    Start Date concomitant medication
    Beschrijving

    Time is optional.

    Datatype

    partialDatetime

    Alias
    UMLS CUI [1,1]
    C2826734
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C0024117
    Stop Date concomitant medication
    Beschrijving

    Time is optional

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2826744
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C0024117
    Ongoing?
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826666
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C0024117
    Medication type
    Beschrijving

    This item will be calculated by InForm. [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C2826257
    UMLS CUI [1,4]
    C0024117
    COPD concomitant medications
    Beschrijving

    COPD concomitant medications

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0024117
    Sequence number
    Beschrijving

    [hidden]

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2348184
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0024117
    Drug name
    Beschrijving

    (Trade Name preferred)

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0024117
    Modified reported term
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826819
    UMLS CUI [1,2]
    C0024117
    GSK Drug synonym
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C2826819
    UMLS CUI [1,3]
    C0871468
    GSK Drug Collection code
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C2826819
    UMLS CUI [1,3]
    C1516698
    UMLS CUI [1,4]
    C0805701
    Failed coding
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0805701
    UMLS CUI [1,4]
    C0231175
    Unit Dose
    Beschrijving

    This item is conditional

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826646
    UMLS CUI [1,2]
    C0024117
    Units
    Beschrijving

    This item is conditional

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0439148
    Frequency
    Beschrijving

    This item is conditional

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826654
    UMLS CUI [1,2]
    C0024117
    Route
    Beschrijving

    This item is optional

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826730
    UMLS CUI [1,2]
    C0024117
    Start Date
    Beschrijving

    Time is optional

    Datatype

    partialDatetime

    Alias
    UMLS CUI [1,1]
    C2826734
    UMLS CUI [1,2]
    C0024117
    Ongoing?
    Beschrijving

    COPD Concomitant medication ongoing

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826666
    UMLS CUI [1,2]
    C0024117
    If not ongoing specify End Date
    Beschrijving

    Time is optional

    Datatype

    partialDatetime

    Alias
    UMLS CUI [1,1]
    C2826744
    UMLS CUI [1,2]
    C0024117
    Was drug administered for an exacerbation?
    Beschrijving

    This item is optional

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C3469597
    UMLS CUI [1,4]
    C0740304
    Concomitant medications
    Beschrijving

    Concomitant medications

    Alias
    UMLS CUI-1
    C2347852
    Sequence number
    Beschrijving

    [hidden]

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348184
    Drug name
    Beschrijving

    (Trade Name preferred)

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C2347852
    Modified reported term
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826819
    GSK Drug synonym
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826819
    UMLS CUI [1,2]
    C0871468
    GSK Drug Collection code
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826819
    UMLS CUI [1,2]
    C1516698
    UMLS CUI [1,3]
    C0805701
    Failed coding
    Beschrijving

    [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C0231175
    Reason for medication
    Beschrijving

    This item is optional

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826696
    Start Date
    Beschrijving

    Time is optional

    Datatype

    partialDatetime

    Alias
    UMLS CUI [1]
    C2826734
    Taken prior to study?
    Beschrijving

    This item is optional

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826667
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    Ongoing?
    Beschrijving

    Concomitant medication ongoing

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826666
    If not ongoing specify End Date
    Beschrijving

    Time is optional

    Datatype

    partialDatetime

    Alias
    UMLS CUI [1]
    C2826744
    Medication type
    Beschrijving

    This item will be calculated by InForm. [hidden]

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0332307

    Similar models

    COPD and concomitant medication

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject identification number
    Item
    Subject identification number
    text
    C2348585 (UMLS CUI [1])
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Item Group
    COPD Prior concomitant medications
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    C0024117 (UMLS CUI-3)
    Sequence number of prior COPD concomitant agent
    Item
    Sequence number
    integer
    C2348184 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2826257 (UMLS CUI [1,3])
    C0024117 (UMLS CUI [1,4])
    Drug name of prior COPD concomitant agent
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2826257 (UMLS CUI [1,3])
    C0024117 (UMLS CUI [1,4])
    Modified reported term of prior COPD concomitant medication
    Item
    Modified reported term
    text
    C2826819 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    GSK Drug synonym (COPD, prior to study)
    Item
    GSK Drug synonym
    text
    C2826819 (UMLS CUI [1,1])
    C0871468 (UMLS CUI [1,2])
    C2826257 (UMLS CUI [1,3])
    C0024117 (UMLS CUI [1,4])
    GSK prior COPD concomitant medication Collection code
    Item
    GSK Drug Collection code
    text
    C2347852 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    C1516698 (UMLS CUI [1,4])
    C0805701 (UMLS CUI [1,5])
    Prior COPD concomitant medication Failed coding
    Item
    Failed coding
    text
    C2347852 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    C0231175 (UMLS CUI [1,5])
    Start Date prior COPD concomitant medication
    Item
    Start Date concomitant medication
    partialDatetime
    C2826734 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    Stop Date prior COPD concomitant medication
    Item
    Stop Date concomitant medication
    date
    C2826744 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    Item
    Ongoing?
    text
    C2826666 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Prior COPD concomitant medication type
    Item
    Medication type
    text
    C2347852 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C2826257 (UMLS CUI [1,3])
    C0024117 (UMLS CUI [1,4])
    Item Group
    COPD concomitant medications
    C2347852 (UMLS CUI-1)
    C0024117 (UMLS CUI-2)
    Sequence number of COPD concomitant medication
    Item
    Sequence number
    integer
    C2348184 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    COPD concomitant medication Drug name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0024117 (UMLS CUI [1,3])
    Modified reported term for COPD concomitant medication
    Item
    Modified reported term
    text
    C2826819 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    GSK Drug synonym for COPD concomitant medication
    Item
    GSK Drug synonym
    text
    C0024117 (UMLS CUI [1,1])
    C2826819 (UMLS CUI [1,2])
    C0871468 (UMLS CUI [1,3])
    GSK COPD concomitant medication Collection code
    Item
    GSK Drug Collection code
    text
    C0024117 (UMLS CUI [1,1])
    C2826819 (UMLS CUI [1,2])
    C1516698 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    COPD concomitant medication Failed coding
    Item
    Failed coding
    text
    C0024117 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    C0231175 (UMLS CUI [1,4])
    COPD Concomitant medication Unit Dose
    Item
    Unit Dose
    text
    C2826646 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    Item
    Units
    text
    C0024117 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0439148 (UMLS CUI [1,3])
    CL Item
    Actuation (ACTU)
    CL Item
    Ampoule (AMP)
    CL Item
    Bottle (BT)
    CL Item
    Capsule (CAP)
    CL Item
    Cubic centimeter (CC)
    CL Item
    Lozenge (LOZ)
    CL Item
    Microgram/kilogram per minute (MCG/KG/MIN)
    CL Item
    Micrograms per minute (MCG/MIN)
    CL Item
    Minimum alveolar concentration (MAC)
    CL Item
    Nebel (NEB)
    CL Item
    Patch (PAT)
    CL Item
    Puff (PUFF)
    CL Item
    Spray (SPR)
    CL Item
    Tablet (TAB)
    CL Item
    Teaspoon (TSP)
    CL Item
    Units (U)
    CL Item
    Application (APP)
    CL Item
    Area under curve (AUC)
    CL Item
    Cup (CUP)
    CL Item
    Drops (GTT)
    CL Item
    Finger tip unit (FTU)
    CL Item
    Gamma per kilogram per minute (GA/KG/MIN)
    CL Item
    Gram (G)
    CL Item
    Grams per kilogram (G/GK)
    CL Item
    Grams per litre (G/L)
    CL Item
    grams per metre squared (G/M2)
    CL Item
    Grams per millilitre (G/ML)
    CL Item
    Inhalation (INH)
    CL Item
    100 International units/ml (100IU/ML)
    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
    Litre per minute (L/MIN)
    CL Item
    Mega becquerels (MBq) (MBQ)
    CL Item
    Megaunits (million units) (MU)
    CL Item
    Microgram (MCG) (MCG)
    CL Item
    Microgram (UG) (UG)
    CL Item
    Microgram/gram (MCG/G)
    CL Item
    Micrograms per hour (MCG/HR)
    CL Item
    Microgram/kilogram (MCG/KG)
    CL Item
    Micrograms per millilitre (MCG/ML)
    CL Item
    Microlitre (MCL)
    CL Item
    Micromoles (UMOL)
    CL Item
    Micromoles per 24 hours (UMOL/24HR)
    CL Item
    Millicurie (MCI)
    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
    Millilitre (ML)
    CL Item
    Millilitre per hour (ML/HR)
    CL Item
    Millilitre per minute (ML/MIN)
    CL Item
    Millimole (MMOL)
    CL Item
    Millimoles per kilogram (MMOL/KG)
    CL Item
    Millimoles per millilitre (MMOL/ML)
    CL Item
    Million international units (MIU)
    CL Item
    Ounce (OZ)
    CL Item
    Pack (PACK)
    CL Item
    Percent (%)
    CL Item
    Ring (RING)
    CL Item
    Sachet (SACH)
    CL Item
    Suppository (SUPP)
    CL Item
    Tablespoon (TBLSP)
    CL Item
    Units per gram (Units per gram)
    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
    Unknown (UNK)
    CL Item
    Vial (VIAL)
    Item
    Frequency
    text
    C2826654 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    CL Item
    AC (AC)
    CL Item
    Every 3 months (Q3M)
    CL Item
    PC (PC)
    CL Item
    PRN (PRN)
    CL Item
    Q3D (Q3D)
    CL Item
    Q4D (Q4D)
    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
    BID (BID)
    CL Item
    Continuous infection (CINF)
    CL Item
    HS (HS)
    CL Item
    Once daily (OD)
    CL Item
    Once only (ONE)
    CL Item
    Q12H (Q12H)
    CL Item
    Q2H (Q2H)
    CL Item
    Every 2 weeks (Q2WK)
    CL Item
    Every 3 weeks (Q3WK)
    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
    Every other day (QOD)
    CL Item
    Once a month (QM)
    CL Item
    QPM (QPM)
    CL Item
    Once a week (QWK)
    CL Item
    TID (TID)
    CL Item
    Unknown (UNK)
    Item
    Route
    text
    C2826730 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    CL Item
    Epidural (EP)
    CL Item
    Gatrostomy 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
    Jejunostomy feeding tube (JEJ or PEJ) (JEJ)
    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
    Transmucosal (TM)
    CL Item
    Topical (TP)
    CL Item
    Unknown (UNK)
    CL Item
    Vaginal (VG)
    COPD Concomitant medication Start Date
    Item
    Start Date
    partialDatetime
    C2826734 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    Item
    Ongoing?
    text
    C2826666 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    CL Item
    Yes (Y)
    CL Item
    No, specify End Date (N)
    COPD Concomitant medication End Date
    Item
    If not ongoing specify End Date
    partialDatetime
    C2826744 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    Item
    Was drug administered for an exacerbation?
    text
    C0024117 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [1,3])
    C0740304 (UMLS CUI [1,4])
    Code List
    Was drug administered for an exacerbation?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Concomitant medications
    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
    C2826819 (UMLS CUI [1,1])
    C0871468 (UMLS CUI [1,2])
    GSK Drug Collection code
    Item
    GSK Drug Collection code
    text
    C2826819 (UMLS CUI [1,1])
    C1516698 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    CM: Failed coding
    Item
    Failed coding
    text
    C2347852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Reason for concomitant medication
    Item
    Reason for medication
    text
    C2826696 (UMLS CUI [1])
    Concomitant medication Start Date
    Item
    Start Date
    partialDatetime
    C2826734 (UMLS CUI [1])
    Item
    Taken prior to study?
    text
    C2826667 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Code List
    Taken prior to study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Ongoing?
    text
    C2826666 (UMLS CUI [1])
    CL Item
    Yes (Y)
    CL Item
    No, specify End Date (N)
    Concomitant medication End Date
    Item
    If not ongoing specify End Date
    partialDatetime
    C2826744 (UMLS CUI [1])
    Medication type
    Item
    Medication type
    text
    C2347852 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial