ID

43921

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. 3/29/16 3/29/16 -
  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 Questions

English

VX-950HPC3006 NCT01571583 Questions

1 forms  
Questions
Description

Questions

Rash or cutaneous event number
Description

Rash or cutaneous event number

Data type

text

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

itching rash

Data type

integer

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

rash pain

Data type

boolean

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

numb rash

Data type

boolean

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

spot size and shape

Data type

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?
Description

scaly rash scalp

Data type

boolean

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

scaly rash elbow

Data type

boolean

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

scaly rash knees

Data type

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?
Description

if yes, please record on the concomitant therapy form

Data type

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?
Description

topical agent

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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