ID

13898

Descripción

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

Palabras clave

Versiones (1)
  1. 14/3/16 14/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

14 de marzo de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

VX-950HPC3006 Screening Physical Examination

1 formularios  
Date of examination
Descripción

Date of examination

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

Date of examination

Tipo de datos

boolean

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

Other date

Tipo de datos

date

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

General Appearance

Alias
UMLS CUI-1
C1148438
Not done
Descripción

Not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
Normal
Descripción

Normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
Abnormal please specify
Descripción

Abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

Skin and mucous membranes

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

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

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.

Tipo de datos

boolean

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

Eyes

Alias
UMLS CUI-1
C0015392
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

Funduscopic exam

Alias
UMLS CUI-1
C0029090
not done
Descripción

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.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

Alias
UMLS CUI [1]
C0205161
abnormality clinically significant
Descripción

if yes, subject is screening failure

Tipo de datos

boolean

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

date of funduscopic exam

Tipo de datos

integer

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

Ears, nose, throat

Alias
UMLS CUI-1
C0007222
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

Cardiovascular system

Alias
UMLS CUI-1
C0007226
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant?

Tipo de datos

boolean

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

Respiratory system

Alias
UMLS CUI-1
C0035237
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

Gastrointestinal system

Alias
UMLS CUI-1
C0012240
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

Genito-urinary system

Alias
UMLS CUI-1
C0260313
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

is the abnormality clinically significant?

Tipo de datos

boolean

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

neurological system

Alias
UMLS CUI-1
C0027853
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

musculo-skeletal system

Alias
UMLS CUI-1
C0026860
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

lymph nodes

Alias
UMLS CUI-1
C0024204
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

anorectal

Alias
UMLS CUI-1
C3870603
not done
Descripción

not done

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272696
normal
Descripción

normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205307
abnormal please specify
Descripción

abnormal

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

other abnormality

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

new finding only please only one abnormality per row

Tipo de datos

text

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

abnormality clinically significant

Tipo de datos

boolean

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

row number

Tipo de datos

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 Screening Physical Examination

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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