ID
34694
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 informations about any additional, unscheduled laboratory safety tests. It should be checked at each visit if any unscheduled laboratory safety tests were 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 (3)
- 12/3/18 12/3/18 -
- 1/23/19 1/23/19 -
- 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
January 23, 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
Unscheduled Laboratory Safety Test
- StudyEvent: ODM
Description
Screening Unscheduled Laboratory Safety Tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C3854240
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Sample Taken (Biochemistry, Haematology, Urinalysis, Volume)
Data type
text
Alias
- UMLS CUI [1]
- C0200345
- UMLS CUI [2]
- C0005477
- UMLS CUI [3]
- C0018941
- UMLS CUI [4]
- C0042014
- UMLS CUI [5]
- C1287298
Description
Sample Volume
Data type
text
Measurement units
- ml
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C0449468
Description
Reason for Test
Data type
text
Alias
- UMLS CUI [1]
- C0566251
Description
Clinical Staff Initials
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
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Unscheduled Laboratory Safety Test
- StudyEvent: ODM
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C0005477 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0042014 (UMLS CUI [4])
C1287298 (UMLS CUI [5])
C0449468 (UMLS CUI [1,2])
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