ID
33265
Descripción
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
Palabras clave
Versiones (3)
- 3/12/18 3/12/18 -
- 19/12/18 19/12/18 -
- 11/1/19 11/1/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
3 de diciembre de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Effect of Lamictal on Resting Motor Threshold
AE Follow-Up
- StudyEvent: ODM
Descripción
AE Follow-Up
Alias
- UMLS CUI-1
- C1522577
- UMLS CUI-2
- C0877248
Descripción
Adverse Events Reviewed
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1709940
Descripción
If yes, update adverse event source document and provide adverse event follow up letter
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826663
Descripción
If no, provide reason
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
Descripción
Reason Letter Provided
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
- UMLS CUI [1,4]
- C0392360
Descripción
Date Letter Provided
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1096774
- UMLS CUI [1,3]
- C1999230
Descripción
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])