0 Evaluaciones
ID

28848

Descripción

Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Early Withdrawal

Palabras clave

Versiones (2)
  1. 8/2/18 8/2/18 -
  2. 8/2/18 8/2/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

8 de febrero de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723

    Inglés

    Early Withdrawal

    1 formularios  
    1. StudyEvent: ODM
      1. Early Withdrawal
    Adverse Events
    Descripción

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Center
    Descripción

    Center

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject ID
    Descripción

    Subject ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Initials
    Descripción

    Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
    Descripción

    I f 'Yes', record details on the Adverse Events panel.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Concomitant Medications
    Descripción

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    UMLS CUI-2
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
    Descripción

    If 'Yes', record details on the Concomitant Medications panel.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2169461 (recent change in medication)
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Blood Pressure - sitting, Systolic
    Descripción

    Blood Pressure - sitting, Systolic

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0277814 (Sitting position)
    SNOMED
    33586001
    LOINC
    LA11868-9
    mmHg
    Blood Pressure - sitting, Diastolic
    Descripción

    Blood Pressure - sitting, Diastolic

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0277814 (Sitting position)
    SNOMED
    33586001
    LOINC
    LA11868-9
    mmHg
    Heart Rate
    Descripción

    Heart Rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Waist circumference
    Descripción

    Waist circumference

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0455829 (Waist Circumference)
    SNOMED
    276361009
    cm
    Central Laboratory
    Descripción

    Central Laboratory

    Alias
    UMLS CUI-1
    C1880016 (Central Laboratory)
    UMLS CUI-2
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Were lab samples obtained?
    Descripción

    lab samples

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [2]
    C0200354 (Urine Specimen Collection)
    SNOMED
    57617002
    Date Sample Taken
    Descripción

    Date Sample Taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Investigational Product Compliance
    Descripción

    Investigational Product Compliance

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
    Descripción

    Investigational Product Compliance

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    If compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
    Descripción

    Investigational Product Compliance Reason

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,3]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If other reason, please specify
    Descripción

    Investigational Product Compliance Reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,3]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
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    Similar models

    Early Withdrawal

    1 formularios
    1. StudyEvent: ODM
      1. Early Withdrawal
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Center
    Item
    Center
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    adverse events
    Item
    Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    changes concomitant medication
    Item
    Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
    boolean
    C2347852 (UMLS CUI [1,1])
    C2169461 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Blood Pressure - sitting, Systolic
    Item
    Blood Pressure - sitting, Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Blood Pressure - sitting, Diastolic
    Item
    Blood Pressure - sitting, Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Waist circumference
    Item
    Waist circumference
    float
    C0455829 (UMLS CUI [1])
    Item Group
    Central Laboratory
    C1880016 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    lab samples
    Item
    Were lab samples obtained?
    boolean
    C0005834 (UMLS CUI [1])
    C0200354 (UMLS CUI [2])
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Item Group
    Investigational Product Compliance
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    Item
    What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
    integer
    C0304229 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    Investigational Product Compliance
    Code List
    What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
    CL Item
    0% compliant (subject did not take any doses) (1)
    CL Item
    > 0% and < 80% compliant (subject missed a number of doses) (2)
    CL Item
    >=80% and <=120% (number of doses taken was within compliance range) (3)
    CL Item
    > 120% compliant (number of doses taken exceeds compliance limits) (4)
    Item
    If compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
    integer
    C0304229 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    inclusion criteria the subject failed
    Code List
    If compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
    CL Item
    Adverse event (ensure that details are recorded in the Adverse Events panel) (1)
    CL Item
    Dispensing error (2)
    CL Item
    Subject did not take medication according to protocol (3)
    CL Item
    Other (4)
    Investigational Product Compliance Reason
    Item
    If other reason, please specify
    text
    C0304229 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
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