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ID

33524

Description

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about the subjects 12-lead electrocardiogram. All ECGs will be recorder after 10 minutes rest in the semi-supine position. It should be filled out at screening visit. Unscheduled ECGs should be recorded whenever they have been performed Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Mots-clés

Versions (4)
  1. 11/12/2018 11/12/2018 -
  2. 11/12/2018 11/12/2018 -
  3. 08/01/2019 08/01/2019 -
  4. 23/01/2019 23/01/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

11 décembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Anglais

    ECG

    1 Formulaires  
    1. StudyEvent: ODM
      1. ECG
    Administrative Data
    Description

    Administrative Data

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

    Subject Screening No.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject no.
    Description

    Subject Number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date Information Collected
    Description

    Date Information Collected

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C3244127 (information collection)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    12- Lead Electrocardiogram
    Description

    12- Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    Please record RR value
    Description

    Blood pressure

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    Result of ECG one
    Description

    If ECG abnormal and clinically significant, exclude

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0438154 (Electrocardiogram finding)
    SNOMED
    271921002
    ECG comment
    Description

    ECG comment

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    UMLS CUI [1,2]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Unscheduled 12-Lead Electrocardiogram
    Description

    Unscheduled 12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI-2
    C3854240 (Unscheduled)
    SNOMED
    2341000175109
    LOINC
    LA22869-4
    Actual Time
    Description

    Actual Time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Please Record RR Value
    Description

    RR Value

    Type de données

    integer

    Unités de mesure
    • ms
    Alias
    UMLS CUI [1]
    C0489636 (RR interval)
    LOINC
    LP31123-0
    ms
    ECG Result
    Description

    Tick only one

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0438154 (Electrocardiogram finding)
    SNOMED
    271921002
    Comment
    Description

    Please enter reason for repeat of ECG.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Conclusion
    Description

    Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    Staff initials
    Description

    Staff initials

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2986440 (Person Initials)
    UMLS CUI [1,2]
    C1552089 (Staff Member)
    Retour au début de la page

    Similar models

    ECG

    1 Formulaires
    1. StudyEvent: ODM
      1. ECG
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Date Information Collected
    Item
    Date Information Collected
    date
    C3244127 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    12- Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    Blood pressure
    Item
    Please record RR value
    integer
    C0005823 (UMLS CUI [1])
    Item
    Result of ECG one
    integer
    C0438154 (UMLS CUI [1])
    ECG Result
    Code List
    Result of ECG one
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - clinically significant (3)
    CL Item
    No result (Not available) (4)
    ECG comment
    Item
    ECG comment
    text
    C1623258 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Unscheduled 12-Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    RR Value
    Item
    Please Record RR Value
    integer
    C0489636 (UMLS CUI [1])
    Item
    ECG Result
    integer
    C0438154 (UMLS CUI [1])
    ECG Result
    Code List
    ECG Result
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically Significant (If Yes, Exclude (3)
    CL Item
    No result (not available) (4)
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Conclusion
    C1707478 (UMLS CUI-1)
    Staff initials
    Item
    Staff initials
    text
    C2986440 (UMLS CUI [1,1])
    C1552089 (UMLS CUI [1,2])
    Retour au début de la page 

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