ID

14083

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 Laboratory - blood, urine, pregnancy (central lab - uns)

Engels

VX-950HPC3006 Laboratory - Blood, urine, pregnancy (central lab - uns)

1 Formulieren  
Laboratory blood urine pregnancy
Beschrijving

Laboratory blood urine pregnancy

Alias
UMLS CUI-1
C0022877
date of collection
Beschrijving

date of collection

Datatype

integer

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0011008
Outcome of urine pregnancy test
Beschrijving

Outcome of urine pregnancy test

Datatype

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0085565
outcome of urinalysis by dipstick: glucose
Beschrijving

if clinically significant and new or changed since date of informed consent, please report an AE form

Datatype

integer

Alias
UMLS CUI [1,1]
C0017725
UMLS CUI [1,2]
C0430370
outcome of urinalysis by dipstick: protein
Beschrijving

if clinically significant and new or changed since date of informed consent, please report an AE form

Datatype

integer

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C0430370
outcome of urinalysis by dipstick: occult blood
Beschrijving

if clinically significant and new or changed since date of informed consent, please report an AE form

Datatype

integer

Alias
UMLS CUI [1]
C2188744
remarks regarding sample collection, if any
Beschrijving

remarks

Datatype

text

Alias
UMLS CUI [1]
C0947611
clinically significant abnormalities?
Beschrijving

overall interpretation of laboratory report(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
central laboratory reference number
Beschrijving

sample reference numbers

Datatype

text

Alias
UMLS CUI [1,1]
C2826265
UMLS CUI [1,2]
C1880016
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Similar models

VX-950HPC3006 Laboratory - Blood, urine, pregnancy (central lab - uns)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Laboratory blood urine pregnancy
C0022877 (UMLS CUI-1)
Item
date of collection
integer
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
date of collection
Code List
date of collection
CL Item
same date as visit date (1)
CL Item
other date please specify (2)
Item
Outcome of urine pregnancy test
integer
C0430056 (UMLS CUI [1,1])
C0085565 (UMLS CUI [1,2])
Outcome of urine pregnancy test
Code List
Outcome of urine pregnancy test
CL Item
positive (1)
CL Item
negative (2)
CL Item
not applicable (3)
CL Item
not done (4)
Item
outcome of urinalysis by dipstick: glucose
integer
C0017725 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
glucose dipstick
Code List
outcome of urinalysis by dipstick: glucose
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
Item
outcome of urinalysis by dipstick: protein
integer
C0033684 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
protein dipstick
Code List
outcome of urinalysis by dipstick: protein
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
Item
outcome of urinalysis by dipstick: occult blood
integer
C2188744 (UMLS CUI [1])
occult blood dipstick
Code List
outcome of urinalysis by dipstick: occult blood
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
remarks
Item
remarks regarding sample collection, if any
text
C0947611 (UMLS CUI [1])
abnormality clinically significant
Item
clinically significant abnormalities?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
central laboratory reference number
Item
central laboratory reference number
text
C2826265 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
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