ID

33523

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

Keywords

Versions (4)
  1. 12/11/18 12/11/18 -
  2. 12/11/18 12/11/18 -
  3. 1/8/19 1/8/19 -
  4. 1/23/19 1/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 11, 2018

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

ECG

1 forms  
  1. StudyEvent: ODM
    1. ECG
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
12- Lead Electrocardiogram
Description

12- Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Please record RR value
Description

Blood pressure

Data type

integer

Alias
UMLS CUI [1]
C0005823
Result of ECG one
Description

If ECG abnormal and clinically significant, exclude

Data type

integer

Alias
UMLS CUI [1]
C0438154
ECG comment
Description

ECG comment

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
Unscheduled 12-Lead Electrocardiogram
Description

Unscheduled 12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3854240
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Please Record RR Value
Description

RR Value

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
ECG Result
Description

Tick only one

Data type

integer

Alias
UMLS CUI [1]
C0438154
Comment
Description

Please enter reason for repeat of ECG.

Data type

text

Alias
UMLS CUI [1]
C0947611
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
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Similar models

ECG

1 forms
  1. StudyEvent: ODM
    1. ECG
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
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])
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