ID

14086

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 Rash or cutaneous event (Day 0)

English

VX-950HPC3006 NCT01571583 Rash or cutaneous event

1 forms  
Rash or cutaneous event
Description

Rash or cutaneous event

Date of visit
Description

Date of visit

Data type

datetime

Alias
UMLS CUI [1]
C1320303
Should this visit be marked as deleted?
Description

If yes, please complete the check box, else leave blank

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1880274
corresponding adverse event on AE form
Description

adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
is there any associated pruritus with the rash?
Description

pruritus

Data type

boolean

Alias
UMLS CUI [1]
C0033774
UMLS CUI [2]
C0015230
did the pruritus predate the rash?
Description

if yes, please report the pruritus as a separate event on the AE form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0033774
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0015230
lymph node involvement
Description

if yes, please describe (i.e. location, single or multiple)

Data type

boolean

Alias
UMLS CUI [1]
C0806692
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
office use only
Description

office use only

Data type

text

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Similar models

VX-950HPC3006 NCT01571583 Rash or cutaneous event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Rash or cutaneous event
Date of visit
Item
Date of visit
datetime
C1320303 (UMLS CUI [1])
Item
Should this visit be marked as deleted?
integer
C0545082 (UMLS CUI [1,1])
C1880274 (UMLS CUI [1,2])
deleted visit
Code List
Should this visit be marked as deleted?
CL Item
deleted (1)
adverse event
Item
corresponding adverse event on AE form
text
C0877248 (UMLS CUI [1])
pruritus
Item
is there any associated pruritus with the rash?
boolean
C0033774 (UMLS CUI [1])
C0015230 (UMLS CUI [2])
pruritus before rash
Item
did the pruritus predate the rash?
boolean
C0033774 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0015230 (UMLS CUI [1,3])
lymph node involvement
Item
lymph node involvement
boolean
C0806692 (UMLS CUI [1])
rash or cutaneous event number
Item
rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
office use only
Item
office use only
text
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