0 Ratings
ID

38878

Description

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Keywords

Versions (1)
  1. 11/11/19 11/11/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 11, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

    English

    Screening - Medical Conditions; Alcohol Intake; Drug and Alcohol Screen; Serology (HIV Screen); Electronically Transferred Lab Data

    1 forms  
    Medical Conditions
    Description

    Medical Conditions

    Alias
    UMLS CUI-1
    C0012634
    Diagnosis
    Description

    Only in the absence of a diagnosis, record the signs and symptoms on separate lines

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Status
    Description

    Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449438
    Alcohol Intake
    Description

    Alcohol Intake

    Alias
    UMLS CUI-1
    C0001948
    Does the subject consume alcohol?
    Description

    Does the subject consume alcohol?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001948
    If subject consumes alcohol, record the average number of units of alcohol consumed per week
    Description

    If subject consumes alcohol, record the average number of units of alcohol consumed per week

    Data type

    float

    Measurement units
    • units per week
    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0560579
    units per week
    Drug and Alcohol Sreen
    Description

    Drug and Alcohol Sreen

    Alias
    UMLS CUI-1
    C0373483
    UMLS CUI-2
    C0001948
    Drug and Alcohol Sreen - Date and time of sample taken
    Description

    Drug and Alcohol Sreen - Date and time of sample taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C0001948
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0040223
    UMLS CUI [2,3]
    C0200345
    Cocaine
    Description

    Cocaine

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0009170
    Amphetamines
    Description

    Amphetamines

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0002667
    Benzodiazepines
    Description

    Benzodiazepines

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005064
    Cannabinoids
    Description

    Cannabinoids

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0006864
    Opiates
    Description

    Opiates

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0376196
    Barbiturates
    Description

    Barbiturates

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0004745
    Methadone
    Description

    Methadone

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0025605
    Alcohol
    Description

    Alcohol

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0001948
    Serology - HIV Screen
    Description

    Serology - HIV Screen

    Alias
    UMLS CUI-1
    C0036743
    UMLS CUI-2
    C0459958
    HIV Screen - Date sample taken
    Description

    HIV Screen - Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0459958
    UMLS CUI [1,2]
    C1302413
    HIV antibody
    Description

    HIV antibody

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019683
    Hepatitis B surface antigen
    Description

    Hepatitis B surface antigen

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019168
    Hepatitis C antibody
    Description

    Hepatitis C antibody

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0201487
    Electronically Transferred Laboratory Data
    Description

    Electronically Transferred Laboratory Data

    Alias
    UMLS CUI-1
    C0745590
    UMLS CUI-2
    C1705822
    Clinical Chemistry - Date Sample Taken
    Description

    Clinical Chemistry - Date Sample Taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1302413
    Clinical Chemistry - Actual Time
    Description

    Clinical Chemistry - Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0040223
    Haematology - Date Sample Take
    Description

    Haematology - Date Sample Take

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C1302413
    Haematology - Actual Time
    Description

    Haematology - Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0040223
    Urinalysis - Date Sample Taken
    Description

    Urinalysis - Date Sample Taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1302413
    Urinalysis - Actual Time
    Description

    Urinalysis - Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
    Back to the top of the page

    Similar models

    Screening - Medical Conditions; Alcohol Intake; Drug and Alcohol Screen; Serology (HIV Screen); Electronically Transferred Lab Data

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Medical Conditions
    C0012634 (UMLS CUI-1)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Status
    integer
    C0449438 (UMLS CUI [1])
    Status
    Code List
    Status
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item Group
    Alcohol Intake
    C0001948 (UMLS CUI-1)
    Does the subject consume alcohol?
    Item
    Does the subject consume alcohol?
    boolean
    C0001948 (UMLS CUI [1])
    If subject consumes alcohol, record the average number of units of alcohol consumed per week
    Item
    If subject consumes alcohol, record the average number of units of alcohol consumed per week
    float
    C0001948 (UMLS CUI [1,1])
    C0560579 (UMLS CUI [1,2])
    Item Group
    Drug and Alcohol Sreen
    C0373483 (UMLS CUI-1)
    C0001948 (UMLS CUI-2)
    Drug and Alcohol Sreen - Date and time of sample taken
    Item
    Drug and Alcohol Sreen - Date and time of sample taken
    datetime
    C0373483 (UMLS CUI [1,1])
    C0001948 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2,1])
    C0040223 (UMLS CUI [2,2])
    C0200345 (UMLS CUI [2,3])
    Item
    Cocaine
    integer
    C0009170 (UMLS CUI [1])
    Cocaine
    Code List
    Cocaine
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Amphetamines
    integer
    C0002667 (UMLS CUI [1])
    Amphetamines
    Code List
    Amphetamines
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Benzodiazepines
    integer
    C0005064 (UMLS CUI [1])
    Benzodiazepines
    Code List
    Benzodiazepines
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Cannabinoids
    integer
    C0006864 (UMLS CUI [1])
    Cannabinoids
    Code List
    Cannabinoids
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Opiates
    integer
    C0376196 (UMLS CUI [1])
    Opiates
    Code List
    Opiates
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Barbiturates
    integer
    C0004745 (UMLS CUI [1])
    Barbiturates
    Code List
    Barbiturates
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Methadone
    integer
    C0025605 (UMLS CUI [1])
    Methadone
    Code List
    Methadone
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Alcohol
    integer
    C0001948 (UMLS CUI [1])
    Alcohol
    Code List
    Alcohol
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Serology - HIV Screen
    C0036743 (UMLS CUI-1)
    C0459958 (UMLS CUI-2)
    HIV Screen - Date sample taken
    Item
    HIV Screen - Date sample taken
    date
    C0459958 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Item
    HIV antibody
    integer
    C0019683 (UMLS CUI [1])
    HIV antibody
    Code List
    HIV antibody
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Hepatitis B surface antigen
    integer
    C0019168 (UMLS CUI [1])
    Hepatitis B surface antigen
    Code List
    Hepatitis B surface antigen
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Hepatitis C antibody
    integer
    C0201487 (UMLS CUI [1])
    Hepatitis C antibody
    Code List
    Hepatitis C antibody
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Electronically Transferred Laboratory Data
    C0745590 (UMLS CUI-1)
    C1705822 (UMLS CUI-2)
    Clinical Chemistry - Date Sample Taken
    Item
    Clinical Chemistry - Date Sample Taken
    date
    C0008000 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Clinical Chemistry - Actual Time
    Item
    Clinical Chemistry - Actual Time
    time
    C0008000 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Haematology - Date Sample Take
    Item
    Haematology - Date Sample Take
    date
    C0018941 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Haematology - Actual Time
    Item
    Haematology - Actual Time
    time
    C0018941 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Urinalysis - Date Sample Taken
    Item
    Urinalysis - Date Sample Taken
    date
    C0042014 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Urinalysis - Actual Time
    Item
    Urinalysis - Actual Time
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Back to the top of the page 

    Help

    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