ID

14089

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 (1)
  1. 3/29/16 3/29/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 29, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

VX-950HPC3006 NCT01571583 Primary Lesions

English

VX-950HPC3006 NCT01571583 Primary Lesions

1 forms  
Primary Lesions
Description

Primary Lesions

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
type
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0332307
number of lesions
Description

number of lesions

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C1265611
largest lesion
Description

largest lesion

Data type

integer

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0443228
smallest lesion
Description

smallest lesion

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C2700395
shape of lesion
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1]
C2168701
location of lesion on skin
Description

location of lesion on skin

Data type

integer

Alias
UMLS CUI [1,1]
C2184261
UMLS CUI [1,2]
C1123023
location of lesion on mucous membrane
Description

location of lesion on mucous membrane

Data type

integer

Alias
UMLS CUI [1,1]
C2184261
UMLS CUI [1,2]
C0026724
distribution
Description

distribution

Data type

integer

Alias
UMLS CUI [1]
C1704711
arrangement
Description

arrangement

Data type

integer

Alias
UMLS CUI [1]
C0449830
color
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1]
C1880121
texture/surface
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1]
C0423752
UMLS CUI [2]
C0205148
margin
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1]
C0205284
Back to the top of the page

Similar models

VX-950HPC3006 NCT01571583 Primary Lesions

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Primary Lesions
Rash or cutaneous event number
Item
Rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
type
integer
C0037284 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
type
Code List
type
CL Item
macule (1)
CL Item
papule (2)
CL Item
nodule (3)
CL Item
plaque (4)
CL Item
wheal (5)
CL Item
vesicle (6)
CL Item
bulla (7)
CL Item
pustule (8)
CL Item
other: (9)
Item
number of lesions
integer
C0221198 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
number of lesions
Code List
number of lesions
CL Item
single (1)
CL Item
multiple (2)
Item
largest lesion
integer
C0037284 (UMLS CUI [1,1])
C0443228 (UMLS CUI [1,2])
largest lesion
Code List
largest lesion
CL Item
largest diameter (mm): (1)
CL Item
perpendicular diameter (mm): (2)
Item
smallest lesion
integer
C0221198 (UMLS CUI [1,1])
C2700395 (UMLS CUI [1,2])
smallest lesion
Code List
smallest lesion
CL Item
less than 1 mm² (1)
CL Item
largest diameter (mm): (2)
CL Item
perpendicular diameter (mm): (3)
Item
shape of lesion
integer
C2168701 (UMLS CUI [1])
shape of lesion
Code List
shape of lesion
CL Item
round (1)
CL Item
linear (2)
CL Item
oval (3)
CL Item
umbilicated (4)
CL Item
target (5)
CL Item
irregular (6)
CL Item
other: (7)
Item
location of lesion on skin
integer
C2184261 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
location of lesion on skin
Code List
location of lesion on skin
CL Item
not applicable (1)
CL Item
lower limbs proximal (2)
CL Item
lower limbs distal (3)
CL Item
upper limbs proximal (4)
CL Item
upper limbs distal (5)
CL Item
trunk (6)
CL Item
back (7)
CL Item
palms or soles (8)
CL Item
buttocks (9)
CL Item
face (10)
CL Item
neck (11)
CL Item
scalp (12)
CL Item
genital (external) (13)
CL Item
other: (14)
Item
location of lesion on mucous membrane
integer
C2184261 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
location of lesion on mucous membrane
Code List
location of lesion on mucous membrane
CL Item
not applicable (1)
CL Item
oral (2)
CL Item
anal (3)
CL Item
vaginal or vulva (4)
CL Item
urethral (distal or visible) (5)
CL Item
eye or conjunctival (6)
CL Item
nasal (7)
CL Item
other: (8)
Item
distribution
integer
C1704711 (UMLS CUI [1])
distribution
Code List
distribution
CL Item
bilateral (1)
CL Item
unilateral (2)
CL Item
midline (3)
Item
arrangement
integer
C0449830 (UMLS CUI [1])
arrangement
Code List
arrangement
CL Item
not applicable (in case of a single lesion) (1)
CL Item
clustered (2)
CL Item
linear (3)
CL Item
scattered (4)
CL Item
dermatoma (5)
CL Item
other: (6)
Item
color
integer
C1880121 (UMLS CUI [1])
color
Code List
color
CL Item
red (1)
CL Item
blue (2)
CL Item
black (3)
CL Item
purple (4)
CL Item
white (5)
CL Item
other: (6)
Item
texture/surface
integer
C0423752 (UMLS CUI [1])
C0205148 (UMLS CUI [2])
texture/surface
Code List
texture/surface
CL Item
scaly (1)
CL Item
crusted (2)
CL Item
smooth (3)
CL Item
sclerotic (4)
CL Item
raised (5)
CL Item
other: (6)
Item
margin
integer
C0205284 (UMLS CUI [1])
margin
Code List
margin
CL Item
sharply defined (1)
CL Item
vaguely defined (2)
CL Item
smooth (3)
CL Item
raised (4)
CL Item
other: (5)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial