ID

13899

Description

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

Mots-clés

Versions (1)
  1. 14/03/2016 14/03/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

14 mars 2016

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.

VX-950HPC3006 NCT01571583 Laboratory Blood Urine Pregnancy

Anglais

VX-950HPC3006 Laboratory - Blood, urine, pregnancy

1 Formulaires  
Laboratory blood urine pregnancy
Description

Laboratory blood urine pregnancy

Alias
UMLS CUI-1
C0022877
date of collection
Description

date of collection

Type de données

integer

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0011008
outcome of urinalysis by dipstick: glucose
Description

if clinically significant and new or changed since date of informed consent, please report an AE form

Type de données

integer

Alias
UMLS CUI [1,1]
C0017725
UMLS CUI [1,2]
C0430370
outcome of urinalysis by dipstick: protein
Description

if clinically significant and new or changed since date of informed consent, please report an AE form

Type de données

integer

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C0430370
outcome of urinalysis by dipstick: occult blood
Description

if clinically significant and new or changed since date of informed consent, please report an AE form

Type de données

integer

Alias
UMLS CUI [1]
C2188744
remarks regarding sample collection, if any
Description

remarks

Type de données

text

Alias
UMLS CUI [1]
C0947611
clinically significant abnormalities?
Description

overall interpretation of laboratory report(s)

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
central laboratory reference number
Description

sample reference numbers

Type de données

text

Alias
UMLS CUI [1,1]
C2826265
UMLS CUI [1,2]
C1880016
Retour au début de la page

Similar models

VX-950HPC3006 Laboratory - Blood, urine, pregnancy

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Laboratory blood urine pregnancy
C0022877 (UMLS CUI-1)
Item
date of collection
integer
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
date of collection
Code List
date of collection
CL Item
same date as visit date (1)
CL Item
other date please specify (2)
Item
outcome of urinalysis by dipstick: glucose
integer
C0017725 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
glucose dipstick
Code List
outcome of urinalysis by dipstick: glucose
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
Item
outcome of urinalysis by dipstick: protein
integer
C0033684 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
protein dipstick
Code List
outcome of urinalysis by dipstick: protein
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
Item
outcome of urinalysis by dipstick: occult blood
integer
C2188744 (UMLS CUI [1])
occult blood dipstick
Code List
outcome of urinalysis by dipstick: occult blood
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
remarks
Item
remarks regarding sample collection, if any
text
C0947611 (UMLS CUI [1])
abnormality clinically significant
Item
clinically significant abnormalities?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
central laboratory reference number
Item
central laboratory reference number
text
C2826265 (UMLS CUI [1,1])
C1880016 (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