ID
34017
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 on adverse events that ocurred during the study. It should be filled out at the follow up visit. It should be filled out at 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 -
- 19-12-18 19-12-18 -
- 11-01-19 11-01-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 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
AE Follow-Up
- StudyEvent: ODM
Beschrijving
AE Follow-Up
Alias
- UMLS CUI-1
- C1522577
- UMLS CUI-2
- C0877248
Beschrijving
Adverse Events Reviewed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1709940
Beschrijving
If yes, update adverse event source document and provide adverse event follow up letter
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826663
Beschrijving
If no, provide reason If yes, provide date
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
Beschrijving
Reason Letter Not Provided
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
- UMLS CUI [1,4]
- C0392360
- UMLS CUI [1,5]
- C1272696
Beschrijving
Date Letter Provided
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
Beschrijving
Conclusion
Alias
- UMLS CUI-1
- C1707478
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AE Follow-Up
- StudyEvent: ODM
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