ID

43921

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 (2)
  1. 29/03/16 29/03/16 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

CC BY-NC 3.0

Caricato su

20 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Questions

Inglese

VX-950HPC3006 NCT01571583 Questions

1 moduli  
Questions
Descrizione

Questions

Rash or cutaneous event number
Descrizione

Rash or cutaneous event number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
Does the rash itch?
Descrizione

itching rash

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0033774
is the area of the rash painful like sunburn?
Descrizione

rash pain

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0030193
is the area of the rash numb?
Descrizione

numb rash

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0028643
are the spots similar in size and shape to insect bites?
Descrizione

spot size and shape

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1705203
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2168701
does the subject have any scaling rash involving the scalp?
Descrizione

scaly rash scalp

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0234922
UMLS CUI [1,2]
C0036270
does the subject have any scaling rash involving the elbows?
Descrizione

scaly rash elbow

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0234922
UMLS CUI [1,2]
C0013769
does the subject have any scaling rash involving the knees?
Descrizione

scaly rash knees

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0234922
UMLS CUI [1,2]
C0022742
to your knowledge, has the subject started any new drugs in the past month prior to the onset of the rash, including vitamins, over the counter medication, homeopathic medication or herbal products/preparations?
Descrizione

if yes, please record on the concomitant therapy form

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3506384
UMLS CUI [1,2]
C0040223
to your knowledge, has the subject used any new topical agents in the past month prior to the onset of the rash, including soaps, detergents, washing powders, perfumes, creams, fabric softeners?
Descrizione

topical agent

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1710439
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0040223
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Similar models

VX-950HPC3006 NCT01571583 Questions

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Questions
Rash or cutaneous event number
Item
Rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Does the rash itch?
integer
C0015230 (UMLS CUI [1,1])
C0033774 (UMLS CUI [1,2])
itching rash
Code List
Does the rash itch?
CL Item
yes, and the itch came before the rash appeared (1)
CL Item
yes, and the itch came after the rash appeared (2)
CL Item
no (3)
rash pain
Item
is the area of the rash painful like sunburn?
boolean
C0015230 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
numb rash
Item
is the area of the rash numb?
boolean
C0015230 (UMLS CUI [1,1])
C0028643 (UMLS CUI [1,2])
spot size and shape
Item
are the spots similar in size and shape to insect bites?
boolean
C1705203 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2168701 (UMLS CUI [1,3])
scaly rash scalp
Item
does the subject have any scaling rash involving the scalp?
boolean
C0234922 (UMLS CUI [1,1])
C0036270 (UMLS CUI [1,2])
scaly rash elbow
Item
does the subject have any scaling rash involving the elbows?
boolean
C0234922 (UMLS CUI [1,1])
C0013769 (UMLS CUI [1,2])
scaly rash knees
Item
does the subject have any scaling rash involving the knees?
boolean
C0234922 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
new drug
Item
to your knowledge, has the subject started any new drugs in the past month prior to the onset of the rash, including vitamins, over the counter medication, homeopathic medication or herbal products/preparations?
boolean
C3506384 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
to your knowledge, has the subject used any new topical agents in the past month prior to the onset of the rash, including soaps, detergents, washing powders, perfumes, creams, fabric softeners?
integer
C1710439 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
topical agent
Code List
to your knowledge, has the subject used any new topical agents in the past month prior to the onset of the rash, including soaps, detergents, washing powders, perfumes, creams, fabric softeners?
CL Item
yes, please specify: (1)
CL Item
no (2)
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