ID

34693

Beskrivning

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 Unscheduled ECGs should be documented in this form whenever they are performed during the study. If an ECG is deemed Abnormal, clinically significant, complete the “ECG Abnormalities” page in the CRF. 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

Nyckelord

  1. 2019-01-23 2019-01-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Unscheduled 12-Lead ECG Form

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

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

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Unscheduled 12-Lead Electrocardiogram
Beskrivning

Unscheduled 12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3854240
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Reason for Unscheduled Assessment
Beskrivning

Reason for Unscheduled Assessment

Datatyp

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C0392360
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Comment Key
Beskrivning

Comment Key

Datatyp

integer

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1706198
Clinical Staff Initials
Beskrivning

Clinical Staff Initials

Datatyp

text

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

Similar models

Unscheduled 12-Lead ECG Form

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Unscheduled 12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Reason for Unscheduled Assessment
Item
Reason for Unscheduled Assessment
text
C0220825 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item
Comment Key
integer
C0947611 (UMLS CUI [1,1])
C1706198 (UMLS CUI [1,2])
Code List
Comment Key
CL Item
Not done due to adverse event (describe) (1)
CL Item
Late due to late running of previous assessment (2)
CL Item
Subject not in attendance (confirm time delay) (3)
CL Item
Late due to technical problems (confirm time delay) (4)
CL Item
Other (describe) (5)
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])

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