ID

14085

Beschrijving

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

Trefwoorden

Versies (1)
  1. 29-03-16 29-03-16 -
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CC BY-NC 3.0

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29 maart 2016

DOI

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Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Local Laboratory

Engels

VX-950HPC3006 NCT01571583 Local Laboratory

1 Formulieren  
Date of sampling
Beschrijving

Date of sampling

Alias
UMLS CUI-1
C0870078
UMLS CUI-2
C0011008
date and time of collection
Beschrijving

collection date

Datatype

integer

Alias
UMLS CUI [1]
C1317250
local laboratory name
Beschrijving

local laboratory name

Datatype

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C1301943
remarks regarding sample collection, if any
Beschrijving

remarks

Datatype

text

Alias
UMLS CUI [1]
C0947611
clinically significant results
Beschrijving

clinically significant results

Datatype

boolean

Alias
UMLS CUI [1]
C2826633
Local laboratory results entry
Beschrijving

Local laboratory results entry

lab method
Beschrijving

lab method

Datatype

integer

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C1881193
UMLS CUI [3]
C0201916
UMLS CUI [4]
C0373670
UMLS CUI [5]
C0201883
UMLS CUI [6]
C0202035
value
Beschrijving

value

Datatype

text

Alias
UMLS CUI [1]
C1522609
unit
Beschrijving

unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
normal range
Beschrijving

please ensure the unit is the same as the unit for the value

Datatype

integer

Alias
UMLS CUI [1]
C0086715
row number
Beschrijving

(for office use only)

Datatype

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 NCT01571583 Local Laboratory

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of sampling
C0870078 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item
date and time of collection
integer
C1317250 (UMLS CUI [1])
collection date
Code List
date and time of collection
CL Item
same date as visit date (1)
CL Item
other date, please specify (2)
local laboratory name
Item
local laboratory name
text
C0022877 (UMLS CUI [1,1])
C1301943 (UMLS CUI [1,2])
remarks
Item
remarks regarding sample collection, if any
text
C0947611 (UMLS CUI [1])
clinically significant results
Item
clinically significant results
boolean
C2826633 (UMLS CUI [1])
Item Group
Local laboratory results entry
Item
lab method
integer
C1278039 (UMLS CUI [1])
C1881193 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
C0373670 (UMLS CUI [4])
C0201883 (UMLS CUI [5])
C0202035 (UMLS CUI [6])
lab method
Code List
lab method
CL Item
bilirubin total (1)
CL Item
direct bilirubin (2)
CL Item
indirect bilirubin (3)
CL Item
lipase (4)
CL Item
pancreatic amylase (5)
CL Item
GGT (6)
CL Item
other please specify (7)
value
Item
value
text
C1522609 (UMLS CUI [1])
unit
Item
unit
text
C1519795 (UMLS CUI [1])
Item
normal range
integer
C0086715 (UMLS CUI [1])
normal range
Code List
normal range
CL Item
normal range - lower limit: (1)
CL Item
normal range - upper limit: (2)
CL Item
normal range - text based: (3)
row number
Item
row number
text
C0237753 (UMLS CUI [1])
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