ID

14106

Descripción

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

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Versiones (1)
  1. 30/3/16 30/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

30 de marzo de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Biopsy or Dermatologist or Digital Pictures

Inglés

VX-950HPC3006 NCT01571583 Biopsy or Dermatologist or Digital Pictures

1 formularios  
Biopsy or dermatologist or digital pictures
Descripción

Biopsy or dermatologist or digital pictures

rash or cutaneous event number
Descripción

rash or cutaneous event number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
has the subject been examined by a dermatologist?
Descripción

please keep a copy of the dermatologist's report with the source documents

Tipo de datos

integer

Alias
UMLS CUI [1]
C1141976
has a biopsy been taken?
Descripción

please keep a copy of the biopsy report with the source documents

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005558
were pictures taken?
Descripción

please keep a copy of the pictures with the source documents

Tipo de datos

integer

Alias
UMLS CUI [1]
C0441468
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Similar models

VX-950HPC3006 NCT01571583 Biopsy or Dermatologist or Digital Pictures

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Biopsy or dermatologist or digital pictures
rash or cutaneous event number
Item
rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
has the subject been examined by a dermatologist?
integer
C1141976 (UMLS CUI [1])
dermatologic examination
Code List
has the subject been examined by a dermatologist?
CL Item
yes, please specify date of visit (1)
CL Item
no (2)
Item
has a biopsy been taken?
integer
C0005558 (UMLS CUI [1])
biopsy
Code List
has a biopsy been taken?
CL Item
yes please specify date of visit (1)
CL Item
no (2)
Item
were pictures taken?
integer
C0441468 (UMLS CUI [1])
photo
Code List
were pictures taken?
CL Item
yes, please specify date of visit (1)
CL Item
no (2)
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