ID

35197

Description

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders The purpouse of this form is to record the results of the subjects ECG and should be filled out at Visit 1, 6, 7, EW, Day 7 Follow Up and Day 14 Follow Up.

Lien

https://clinicaltrials.gov/ct2/show/NCT00992160

Mots-clés

Versions (3)
  1. 24/02/2019 24/02/2019 -
  2. 01/03/2019 01/03/2019 -
  3. 10/11/2019 10/11/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

24 février 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.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Anglais

12-Lead-ECG

1 Formulaires  
  1. StudyEvent: ODM
    1. 12-Lead-ECG
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Description

Date of Visit/Assessment

Type de données

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Site
Description

Site

Type de données

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Type de données

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Patient No.

Type de données

text

Alias
UMLS CUI [1]
C1830427
12-Lead-ECG
Description

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Dosing Date
Description

This item applies for all visit except visit 1

Type de données

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing Time
Description

This item applies for all visit except visit 1

Type de données

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Date of ECG
Description

Date of ECG

Type de données

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Type de données

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Result of the ECG
Description

Result of the ECG

Type de données

text

Alias
UMLS CUI [1]
C0438154
Retour au début de la page

Similar models

12-Lead-ECG

1 Formulaires
  1. StudyEvent: ODM
    1. 12-Lead-ECG
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient No.
Item
Patient No.
text
C1830427 (UMLS CUI [1])
Item Group
12-Lead-ECG
C0430456 (UMLS CUI-1)
Dosing Date
Item
Dosing Date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing Time
Item
Dosing Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (Normal)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
CL Item
Abnormal - Clinically significant (complete the AE/orm if the abnormality meets the protocol definition for an AE) (Abnormal - Clinically significant (complete the AE/orm if the abnormality meets the protocol definition for an AE))
CL Item
No result (not available) (No result (not available))
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