ID
33248
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 This form contains informations 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
Nyckelord
Versioner (3)
- 2018-12-03 2018-12-03 -
- 2018-12-14 2018-12-14 -
- 2019-01-09 2019-01-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
Unscheduled Vital Signs
- StudyEvent: ODM
Beskrivning
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Beskrivning
Measurement of Unscheduled Vital Signs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0518766
- UMLS CUI [1,3]
- C3854240
Beskrivning
(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)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
Beskrivning
(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)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
- UMLS CUI [1,3]
- C2348235
Beskrivning
If assessment is a repeat of a scheduled time point please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C1948053
Beskrivning
If assessment is a repeat of a scheduled time point please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C2826182
Beskrivning
If assessment is a repeat of a scheduled time point please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Date of Assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Actual Time
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
Position of Measurement
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Beskrivning
Other Position of Measurement Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
- UMLS CUI [1,3]
- C2348235
Beskrivning
Pulse Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Unscheduled Vital Signs
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C0518766 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
C1718255 (UMLS CUI [1,2])
C1718255 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1262869 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])