ID

14122

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. 30/03/2016 30/03/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

30 mars 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

Anglais

VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

1 Formulaires  
Vital signs and anthropometric measurements
Description

Vital signs and anthropometric measurements

rash or cutaneous event number
Description

rash or cutaneous event number

Type de données

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
Date performed
Description

Date performed

Type de données

integer

Alias
UMLS CUI [1]
C0011008
if other date, please specify
Description

other date

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205394
Weight
Description

Weight

Type de données

text

Alias
UMLS CUI [1]
C0005910
Pulse supine
Description

after 5 minutes in supine position at rest

Type de données

text

Unités de mesure
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
beats/min
Blood pressure supine
Description

after 5 minutes in supine position at rest

Type de données

text

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
Clinically significant abnormalities
Description

Clinically significant abnormalities

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
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Similar models

VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Vital signs and anthropometric measurements
rash or cutaneous event number
Item
rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Date performed
integer
C0011008 (UMLS CUI [1])
Date performed
Code List
Date performed
CL Item
Same date as visit date (1)
CL Item
other date please specify (2)
other date
Item
if other date, please specify
date
C0011008 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Pulse supine
Item
Pulse supine
text
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Blood pressure supine
Item
Blood pressure supine
text
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Clinically significant abnormalities
Item
Clinically significant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Retour au début de la page 

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