ID

43799

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

Palabras clave

Versiones (2)
  1. 10/3/16 10/3/16 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 12-lead ECG

Inglés

VX-950HPC3006 12-lead ECG

1 formularios  
12-lead Electrocardiogram
Descripción

12-lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date performed
Descripción

Date performed

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Time performed
Descripción

Time performed

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
RR Interval
Descripción

Tick ms if RR INterval has been provided. In case RR interval could not be provided please provide HR and tick beats per minute.

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489636
msec
Heart rate
Descripción

Tick ms if RR INterval has been provided. In case RR interval could not be provided please provide HR and tick beats per minute.

Tipo de datos

text

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Calculated QTCF value
Descripción

Calculated QTCF value

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0444686
msec
Local QTCF value
Descripción

Local QTCF value

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0205276
msec
Calculated QTCB value
Descripción

Calculated QTCB value

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0444686
msec
Local QTCB value
Descripción

Local QTCB value

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0205276
msec
PR interval
Descripción

PR interval

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS width
Descripción

QRS width

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0520880
msec
Clinically significant abnormalities
Descripción

If yes, please report on the AE form

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Remarks
Descripción

Remarks

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Calculated RR value
Descripción

Calculated RR value

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2041217
UMLS CUI [1,2]
C0444686
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Similar models

VX-950HPC3006 12-lead ECG

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
12-lead Electrocardiogram
C0430456 (UMLS CUI-1)
Date performed
Item
Date performed
date
C0011008 (UMLS CUI [1])
Time performed
Item
Time performed
time
C0040223 (UMLS CUI [1])
RR Interval
Item
RR Interval
text
C0489636 (UMLS CUI [1])
Heart rate
Item
Heart rate
text
C0018810 (UMLS CUI [1])
Calculated QTCF value
Item
Calculated QTCF value
text
C1882513 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Local QTCF value
Item
Local QTCF value
text
C1882513 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Calculated QTCB value
Item
Calculated QTCB value
text
C1882512 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Local QTCB value
Item
Local QTCB value
text
C1882512 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
PR interval
Item
PR interval
text
C0429087 (UMLS CUI [1])
QRS width
Item
QRS width
text
C0520880 (UMLS CUI [1])
Clinically significant abnormalities
Item
Clinically significant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
Calculated RR value
Item
Calculated RR value
text
C2041217 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Volver a la parte superior de la página 

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