ID

34033

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

January 11, 2019

DOI

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License

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

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 of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Study Visit
Description

Study Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Medical History Update
Description

Medical History Update

Alias
UMLS CUI-1
C0262926
Any changes to the subject's medication regime since the screening visit/since last 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/since last visit?
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
Any clinically significant changes in Physical examination since last assessment?
Description

If Yes, record in Adverse Event source document Only applicable at the follow-up visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C2826293
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's Initials
Description

Physician's Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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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 of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
CL Item
Follow-Up (Follow-Up)
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/since last visit?
boolean
C0580105 (UMLS CUI [1])
Clinically Significant Changes to Medical History
Item
Any clinically significant changes to medical history since screening/since last visit?
boolean
C0262926 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Clincally Significant Changes in Physical Examination
Item
Any clinically significant changes in Physical examination since last assessment?
boolean
C0031809 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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