ID

14136

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

  1. 3/31/16 3/31/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 31, 2016

DOI

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License

Creative Commons BY-NC 3.0

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VX-950HPC3006 NCT01571583 Final rash/cutaneous event evaluation

VX-950HPC3006 NCT01571583 Final rash/cutaneous event evaluation

final rash/cutaneous event evaluation
Description

final rash/cutaneous event evaluation

date of visit
Description

date of visit

Data type

datetime

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

deleted visit

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1880274
rash or cutaneous event number for this subject
Description

rash or cutaneous event number for this subject

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
final investigator's diagnosis
Description

please enter corresponding AE number

Data type

text

Alias
UMLS CUI [1,1]
C0332144
UMLS CUI [1,2]
C0035173
local dermatologist's diagnosis
Description

local dermatologist's diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0259831
date of dermatologist's diagnosis (=date of visit local dermatologist)
Description

date of dermatologist's diagnosis (=date of visit local dermatologist)

Data type

date

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0259831
UMLS CUI [1,3]
C0011008
office use only
Description

office use only

Data type

text

Similar models

VX-950HPC3006 NCT01571583 Final rash/cutaneous event evaluation

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
final rash/cutaneous event evaluation
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])
Code List
should this visit be marked as deleted?
CL Item
deleted (1)
rash or cutaneous event number for this subject
Item
rash or cutaneous event number for this subject
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
final investigator's diagnosis
Item
final investigator's diagnosis
text
C0332144 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
local dermatologist's diagnosis
Item
local dermatologist's diagnosis
text
C0011900 (UMLS CUI [1,1])
C0259831 (UMLS CUI [1,2])
date of dermatologist's diagnosis (=date of visit local dermatologist)
Item
date of dermatologist's diagnosis (=date of visit local dermatologist)
date
C0011900 (UMLS CUI [1,1])
C0259831 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
office use only
Item
office use only
text

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