ID

14090

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

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Secondary Lesions / Effects

English

VX-950HPC3006 NCT01571583 Secondary Lesions / Effects

1 forms  
Secondary Lesions
Description

Secondary 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
are there any secondary lesions or effects present?
Description

secondary lesion

Data type

integer

Alias
UMLS CUI [1]
C1519215
type
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0332307
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
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Similar models

VX-950HPC3006 NCT01571583 Secondary Lesions / Effects

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Secondary Lesions
Rash or cutaneous event number
Item
Rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
are there any secondary lesions or effects present?
integer
C1519215 (UMLS CUI [1])
secondary lesion
Code List
are there any secondary lesions or effects present?
CL Item
yes, please complete the question below (1)
CL Item
no, please go to the next assessment (2)
Item
type
integer
C0037284 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
type
Code List
type
CL Item
scales (1)
CL Item
crusts (2)
CL Item
erosion (3)
CL Item
excoriation (4)
CL Item
ulcer (5)
CL Item
scar (6)
CL Item
fissure (7)
CL Item
atrophy (8)
CL Item
lichenification (9)
CL Item
other: (10)
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)
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