ID
33966
Beschrijving
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 measurements of any additional vital signs, not scheduled in the vital signs form. It should be checked at the screening visit, each treatment period and 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
Trefwoorden
Versies (3)
- 03-12-18 03-12-18 -
- 14-12-18 14-12-18 -
- 09-01-19 09-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 januari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Unscheduled Vital Signs
- StudyEvent: ODM
Beschrijving
Unscheduled Vital Signs Conducted
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Beschrijving
Measurement of Unscheduled Vital Signs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0518766
- UMLS CUI [1,3]
- C3854240
Beschrijving
Staff initials
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Beschrijving
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Beschrijving
(See key code below) Key Code: 1. Outside of reference range 2. Protocol requirement 3. Physician request (Specify) 4. Adverse event (Specify) 5. Other (Specify)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
Beschrijving
Reason for Assessment Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
- UMLS CUI [1,3]
- C2348235
Beschrijving
If assessment is a repeat of a scheduled time point please specify
Datatype
text
Alias
- UMLS CUI [1]
- C1948053
Beschrijving
If assessment is a repeat of a scheduled time point please specify
Datatype
text
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
If assessment is a repeat of a scheduled time point please specify
Datatype
text
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Actual Time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Position of Measurement
Datatype
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Beschrijving
Other Position of Measurement Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
- UMLS CUI [1,3]
- C2348235
Beschrijving
Pulse Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Oral Body Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Beschrijving
Respiration Rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Second Position
Alias
- UMLS CUI-1
- C0733755
- UMLS CUI-2
- C0205436
Beschrijving
Actual Time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Position of Measurement
Datatype
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Beschrijving
Pulse Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Conclusion
Alias
- UMLS CUI-1
- C1707478
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Unscheduled Vital Signs
- StudyEvent: ODM
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C3854240 (UMLS CUI-2)
C0518766 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C1718255 (UMLS CUI [1,2])
C1718255 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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C2348235 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,2])
C0871685 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])