ID

34017

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 on adverse events that ocurred during the study. It should be filled out at the follow up visit. It should be filled out at the follow-up visit. 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 (3)
  1. 12/3/18 12/3/18 -
  2. 12/19/18 12/19/18 -
  3. 1/11/19 1/11/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 2019

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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

AE Follow-Up

1 forms  
  1. StudyEvent: ODM
    1. AE Follow-Up
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
AE Follow-Up
Description

AE Follow-Up

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0877248
Has the subject’s adverse events been reviewed?
Description

Adverse Events Reviewed

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1709940
Does the subject have any ongoing adverse event at follow up?
Description

If yes, update adverse event source document and provide adverse event follow up letter

Data type

boolean

Alias
UMLS CUI [1]
C2826663
AE letter given to subject?
Description

If no, provide reason If yes, provide date

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1999230
Reason Letter Not Provided
Description

Reason Letter Not Provided

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1999230
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C1272696
Date Letter Given
Description

Date Letter Provided

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1999230
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Clinical Staff initials
Description

Clinical Staff initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

AE Follow-Up

1 forms
  1. StudyEvent: ODM
    1. AE Follow-Up
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])
Item Group
AE Follow-Up
C1522577 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Adverse Events Reviewed
Item
Has the subject’s adverse events been reviewed?
boolean
C0877248 (UMLS CUI [1,1])
C1709940 (UMLS CUI [1,2])
Adverse Event Ongoing
Item
Does the subject have any ongoing adverse event at follow up?
boolean
C2826663 (UMLS CUI [1])
AE letter Given to Subject
Item
AE letter given to subject?
boolean
C0877248 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
Reason Letter Not Provided
Item
Reason Letter Not Provided
text
C0877248 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C1272696 (UMLS CUI [1,5])
Date Letter Provided
Item
Date Letter Given
date
C0011008 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Clinical Staff initials
Item
Clinical Staff initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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