ID

34723

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 information about any additional, unscheduled laboratory safety tests. It should be checked at each visit if any unscheduled laboratory safety tests were performed. 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)
  1. 03/12/2018 03/12/2018 -
  2. 23/01/2019 23/01/2019 -
  3. 25/01/2019 25/01/2019 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Effect of Lamictal on Resting Motor Threshold Study ID 107434

Anglais

Unscheduled Laboratory Safety Test

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Type de données

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Description

Subject Number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Description

Date Information Collected

Type de données

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Study Day
Description

Study Day

Type de données

text

Alias
UMLS CUI [1]
C2826182
Were any unscheduled laboratory safety tests conducted?
Description

Unscheduled Laboratory Safety Tests

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C3854240
Unscheduled Laboratory Safety Tests
Description

Unscheduled Laboratory Safety Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3854240
Date
Description

Date

Type de données

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Type de données

time

Alias
UMLS CUI [1]
C0040223
Sample Taken (e.g. biochemistry, haematology, urinalysis and volume)
Description

Sample Taken (Biochemistry, Haematology, Urinalysis, Volume)

Type de données

text

Alias
UMLS CUI [1]
C0200345
UMLS CUI [2]
C0005477
UMLS CUI [3]
C0018941
UMLS CUI [4]
C0042014
UMLS CUI [5]
C1287298
Sample Volume
Description

Sample Volume

Type de données

text

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0449468
ml
Reason for Test
Description

Reason for Test

Type de données

text

Alias
UMLS CUI [1]
C0566251
Clinical Staff Initials
Description

Clinical Staff Initials

Type de données

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Retour au début de la page

Similar models

Unscheduled Laboratory Safety Test

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Study Day
text
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Screening (Screening)
CL Item
Post-Screening (Post-Screening)
Unscheduled Laboratory Safety Tests
Item
Were any unscheduled laboratory safety tests conducted?
boolean
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Item Group
Unscheduled Laboratory Safety Tests
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample Taken (Biochemistry, Haematology, Urinalysis, Volume)
Item
Sample Taken (e.g. biochemistry, haematology, urinalysis and volume)
text
C0200345 (UMLS CUI [1])
C0005477 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0042014 (UMLS CUI [4])
C1287298 (UMLS CUI [5])
Sample Volume
Item
Sample Volume
text
C0370003 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Reason for Test
Item
Reason for Test
text
C0566251 (UMLS CUI [1])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial