ID

33252

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 records updates in the medical history of the subject. It should be checked at each visit after the screening. 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

Keywords

Versions (4)
  1. 12/3/18 12/3/18 -
  2. 12/16/18 12/16/18 -
  3. 1/9/19 1/9/19 -
  4. 1/11/19 1/11/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 3, 2018

DOI

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License

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

English

Medical History Update

1 forms  
  1. StudyEvent: ODM
    1. Medical History Update
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Description

Date Information Collected

Data type

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Medical History Update
Description

Medical History Update

Alias
UMLS CUI-1
C0262926
Any changes to the subject's medication regime since the screening visit?
Description

If Yes, record details in the Concomitant Medications source document. Ensure that all medication to be taken whilst the subject is in the Unit is recorded on the appropriate page of the source document.

Data type

boolean

Alias
UMLS CUI [1]
C0580105
Any clinically significant changes to medical history since screening?
Description

If Yes, record in Adverse Event Source Document and label as “Pre dose”. Note: Any updates to the Medical History Pre dose, which are not Serious Adverse Events, will not be reported as an adverse event.

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2826293
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Description

Staff initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Medical History Update

1 forms
  1. StudyEvent: ODM
    1. Medical History Update
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Medical History Update
C0262926 (UMLS CUI-1)
Changes in Medication
Item
Any changes to the subject's medication regime since the screening visit?
boolean
C0580105 (UMLS CUI [1])
Clinically Significant Changes to Medical History
Item
Any clinically significant changes to medical history since screening?
boolean
C0262926 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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