ID

14016

Descrizione

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

Keywords

versioni (1)
  1. 22/03/16 22/03/16 -
Titolare del copyright

CC BY-NC 3.0

Caricato su

22 marzo 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Dispensation of Telaprevir

Inglese

VX-950HPC3006 NCT01571583 Dispensation of Telaprevir

1 moduli  
Dispensation of Telaprevir
Descrizione

Dispensation of Telaprevir

Visit number
Descrizione

Visit number

Tipo di dati

text

Alias
UMLS CUI [1]
C1549755
Date of kit allocation
Descrizione

Date of kit allocation

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1706778
UMLS CUI [1,2]
C0011008
Kit number assigned by IWRS
Descrizione

Kit number assigned by IWRS

Tipo di dati

text

Alias
UMLS CUI [1]
C0237753
Kit number from medication tear off label to be dispensed to subject
Descrizione

Kit number from medication tear off label to be dispensed to subject

Tipo di dati

text

Alias
UMLS CUI [1]
C0237753
Was this kit assigned by IWRS dispensed to the subject?
Descrizione

kit assigned by IWRS dispensed

Tipo di dati

integer

Date of dispensation
Descrizione

Date of dispensation

Tipo di dati

integer

Alias
UMLS CUI [1]
C0011008
Number of tablets taken by subject
Descrizione

Number of tablets

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Kit number returned by subject to site
Descrizione

Kit number

Tipo di dati

integer

Alias
UMLS CUI [1]
C0237753
Date when kit was returned by subject to site
Descrizione

Date when kit was returned by subject to site

Tipo di dati

date

Alias
UMLS CUI [1]
C0011008
Number of tablets in kit returned by subject to site
Descrizione

Number of tablets in kit

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Office use only
Descrizione

Office use only

Tipo di dati

text

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Similar models

VX-950HPC3006 NCT01571583 Dispensation of Telaprevir

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Dispensation of Telaprevir
Visit number
Item
Visit number
text
C1549755 (UMLS CUI [1])
Date of kit allocation
Item
Date of kit allocation
date
C1706778 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Kit number assigned by IWRS
Item
Kit number assigned by IWRS
text
C0237753 (UMLS CUI [1])
Kit number from medication tear off label to be dispensed to subject
Item
Kit number from medication tear off label to be dispensed to subject
text
C0237753 (UMLS CUI [1])
Item
Was this kit assigned by IWRS dispensed to the subject?
integer
undefined item
Code List
Was this kit assigned by IWRS dispensed to the subject?
CL Item
Yes (1)
CL Item
No, misallocated (please contact monitor immediately) (2)
CL Item
No, study medication discontinued (3)
CL Item
No, kit not available at site (please contact IWRS for new kit assignment) (4)
CL Item
No, other please specify (5)
Item
Date of dispensation
integer
C0011008 (UMLS CUI [1])
Date of dispensation
Code List
Date of dispensation
CL Item
Same as date of kit allocation by IWRS (1)
CL Item
other, specify: (2)
Number of tablets
Item
Number of tablets taken by subject
text
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Kit number returned by subject to site
integer
C0237753 (UMLS CUI [1])
Kit number
Code List
Kit number returned by subject to site
CL Item
kit number: (1)
CL Item
N/A (kit never returned) (2)
Date when kit was returned by subject to site
Item
Date when kit was returned by subject to site
date
C0011008 (UMLS CUI [1])
Number of tablets in kit
Item
Number of tablets in kit returned by subject to site
text
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Office use only
Item
Office use only
text
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