ID

40796

Description

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The 12-Lead ECG Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever extra measurements are done during the study (Unscheduled).

Mots-clés

Versions (1)
  1. 15/05/2020 15/05/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

15 mai 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
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.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Anglais

12-Lead ECG

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Type de données

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG number
Description

To be filled in only at pre-dose visits. ECG measurement should be done three times at pre-dose visits.

Type de données

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Description

12 lead ECG; Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Description

12 lead ECG; Start Time

Type de données

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Description

12 lead ECG; Ventricular Rate

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Description

12 lead ECG; PR Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG; QRS complex Duration

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG; QT interval finding

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG; QTc Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Description

Option 4 can be selected only at pre-dose visits. At pre-dose and unscheduled visits: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. At all visits: Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Type de données

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1274040
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)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Screening (Screening)
(Comment:en)
CL Item
Treatment Period 1 Predose (Treatment Period 1 Predose)
(Comment:en)
CL Item
Treatment Period 1 Prior to Discharge (Treatment Period 1 Prior to Discharge)
(Comment:en)
CL Item
Treatment Period 2 Predose (Treatment Period 2 Predose)
(Comment:en)
CL Item
Treatment Period 2 Prior to Discharge (Treatment Period 2 Prior to Discharge)
(Comment:en)
CL Item
Unscheduled (Unscheduled)
(Comment:en)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG; ECG Number
Code List
ECG number
CL Item
ECG1 (1)
(Comment:en)
CL Item
ECG2 (2)
(Comment:en)
CL Item
ECG3 (3)
(Comment:en)
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG; Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG; result
Code List
Result of the ECG
CL Item
Normal (1)
(Comment:en)
CL Item
Abnormal - Not clinically significant  (2)
(Comment:en)
CL Item
Abnormal - Clinically significant (3)
(Comment:en)
CL Item
No result (not available) (4)
(Comment:en)
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