ID
33265
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 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
Mots-clés
Versions (3)
- 03/12/2018 03/12/2018 -
- 19/12/2018 19/12/2018 -
- 11/01/2019 11/01/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
3 décembre 2018
DOI
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Licence
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
AE Follow-Up
- StudyEvent: ODM
Description
AE Follow-Up
Alias
- UMLS CUI-1
- C1522577
- UMLS CUI-2
- C0877248
Description
Adverse Events Reviewed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1709940
Description
If yes, update adverse event source document and provide adverse event follow up letter
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826663
Description
If no, provide reason
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
Description
Reason Letter Provided
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
- UMLS CUI [1,4]
- C0392360
Description
Date Letter Provided
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
AE Follow-Up
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1709940 (UMLS CUI [1,2])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,2])