ID

43907

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

Keywords

Versions (2)
  1. 3/23/16 3/23/16 -
  2. 9/20/21 9/20/21 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 12-lead ECG (Local - Uns)

English

VX-950HPC3006 NCT01571583 12-lead ECG (Local - Uns)

1 forms  
12-lead Electrocardiogram
Description

12-lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date performed
Description

Date performed

Data type

integer

Alias
UMLS CUI [1]
C0011008
Time performed
Description

Time performed

Data type

time

Alias
UMLS CUI [1]
C0040223
RR Interval
Description

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

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
Heart rate
Description

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

Data type

text

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
QT interval
Description

QT interval

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Calculated QTCF value
Description

Calculated QTCF value

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0444686
msec
Local QTCF value
Description

Local QTCF value

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0205276
msec
Calculated QTCB value
Description

Calculated QTCB value

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0444686
msec
Local QTCB value
Description

Local QTCB value

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0205276
msec
PR interval
Description

PR interval

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS width
Description

QRS width

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C0520880
msec
Clinically significant abnormalities
Description

If yes, please report on the AE form

Data type

boolean

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

Remarks

Data type

text

Alias
UMLS CUI [1]
C0947611
Calculated RR value
Description

Calculated RR value

Data type

text

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

VX-950HPC3006 NCT01571583 12-lead ECG (Local - Uns)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-lead Electrocardiogram
C0430456 (UMLS CUI-1)
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)
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])
QT interval
Item
QT interval
text
C1287082 (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])
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