ID

13898

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

Mots-clés

Versions (1)
  1. 14/03/2016 14/03/2016 -
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CC BY-NC 3.0

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14 mars 2016

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Licence

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Screening Physical Examination

Anglais

VX-950HPC3006 Screening Physical Examination

1 Formulaires  
Date of examination
Description

Date of examination

Alias
UMLS CUI-1
C2826643
Same date as visit date
Description

Date of examination

Type de données

boolean

Alias
UMLS CUI [1]
C2826643
UMLS CUI [2]
C1320303
Other date, please specify
Description

Other date

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205394
General Appearance
Description

General Appearance

Alias
UMLS CUI-1
C1148438
Not done
Description

Not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
Normal
Description

Normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
Abnormal please specify
Description

Abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
Is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Skin and mucous membranes
Description

Skin and mucous membranes

Alias
UMLS CUI-1
C1123023
UMLS CUI-2
C0026724
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
Is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
on physical examination ascertained by observer, is there visible flexural dermatitis today?
Description

one or more patches of dermatitis affecting any of the following sites: behind the knees, fronts of ankles, fronts of elbows (antecubital fossae), sides or front of the neck, or around the ears or eyes. Dermatitis may be defined as 'poorly demarcated erythema with surfacing change'. Surface change can mean scalling, crusting, vesicles or lichenification.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011603
UMLS CUI [1,2]
C0439748
Eyes
Description

Eyes

Alias
UMLS CUI-1
C0015392
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
Is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Funduscopic exam
Description

Funduscopic exam

Alias
UMLS CUI-1
C0029090
not done
Description

funduscopic exam and clearance by an ophthalmologist or a similarly qualified healthcare provider is required within 3 months prior to the screening visit or within the screening period for all subjects with diabetes mellitus, hypertension, or known retinal disorders.

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
abnormality clinically significant
Description

if yes, subject is screening failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
date of funduscopic exam
Description

date of funduscopic exam

Type de données

integer

Alias
UMLS CUI [1,1]
C0029090
UMLS CUI [1,2]
C0011008
Ears, nose, throat
Description

Ears, nose, throat

Alias
UMLS CUI-1
C0007222
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Cardiovascular system
Description

Cardiovascular system

Alias
UMLS CUI-1
C0007226
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant?

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Respiratory system
Description

Respiratory system

Alias
UMLS CUI-1
C0035237
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Gastrointestinal system
Description

Gastrointestinal system

Alias
UMLS CUI-1
C0012240
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Genito-urinary system
Description

Genito-urinary system

Alias
UMLS CUI-1
C0260313
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

is the abnormality clinically significant?

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
neurological system
Description

neurological system

Alias
UMLS CUI-1
C0027853
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
musculo-skeletal system
Description

musculo-skeletal system

Alias
UMLS CUI-1
C0026860
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
lymph nodes
Description

lymph nodes

Alias
UMLS CUI-1
C0024204
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
anorectal
Description

anorectal

Alias
UMLS CUI-1
C3870603
not done
Description

not done

Type de données

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Type de données

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Description

abnormal

Type de données

text

Alias
UMLS CUI [1]
C0205161
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
other abnormality
Description

other abnormality

Alias
UMLS CUI-1
C1704258
UMLS CUI-2
C0205394
other abnormality
Description

new finding only please only one abnormality per row

Type de données

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205394
is the abnormality clinically significant?
Description

abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
row number
Description

row number

Type de données

text

Alias
UMLS CUI [1]
C0237753
Retour au début de la page

Similar models

VX-950HPC3006 Screening Physical Examination

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Date of examination
C2826643 (UMLS CUI-1)
Date of examination
Item
Same date as visit date
boolean
C2826643 (UMLS CUI [1])
C1320303 (UMLS CUI [2])
Other date
Item
Other date, please specify
date
C0011008 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
General Appearance
C1148438 (UMLS CUI-1)
Not done
Item
Not done
boolean
C1272696 (UMLS CUI [1])
Normal
Item
Normal
boolean
C0205307 (UMLS CUI [1])
Abnormal
Item
Abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Skin and mucous membranes
C1123023 (UMLS CUI-1)
C0026724 (UMLS CUI-2)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
flexural dermatitis
Item
on physical examination ascertained by observer, is there visible flexural dermatitis today?
boolean
C0011603 (UMLS CUI [1,1])
C0439748 (UMLS CUI [1,2])
Item Group
Eyes
C0015392 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Funduscopic exam
C0029090 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
abnormality clinically significant
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
date of funduscopic exam
integer
C0029090 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
date of funduscopic exam
Code List
date of funduscopic exam
CL Item
same date as visit date (1)
CL Item
other date please specify (2)
Item Group
Ears, nose, throat
C0007222 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Cardiovascular system
C0007226 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant?
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Respiratory system
C0035237 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Gastrointestinal system
C0012240 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Genito-urinary system
C0260313 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
is the abnormality clinically significant?
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
neurological system
C0027853 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
musculo-skeletal system
C0026860 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
lymph nodes
C0024204 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
anorectal
C3870603 (UMLS CUI-1)
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
normal
Item
normal
boolean
C0205307 (UMLS CUI [1])
abnormal
Item
abnormal please specify
text
C0205161 (UMLS CUI [1])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
other abnormality
C1704258 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
other abnormality
Item
other abnormality
text
C1704258 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
abnormality clinically significant
Item
is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
row number
Item
row number
text
C0237753 (UMLS CUI [1])
Retour au début de la page 

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