ID

14116

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. 3/30/16 3/30/16 -
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CC BY-NC 3.0

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March 30, 2016

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License

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VX-950HPC3006 NCT01571583 Physical Examination [FRMPE_PEUNS1]

English

VX-950HPC3006 NCT01571583 Physical Examination [FRMPE_PEUNS1]

1 forms  
Date of examination
Description

Date of examination

Alias
UMLS CUI-1
C2826643
Date of examination
Description

Date of examination

Data type

integer

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

Other date

Data type

datetime

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
Normal
Description

Normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
Abnormal, is the abnormality a new finding?
Description

Abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
Is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
Is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

boolean

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

Eyes

Alias
UMLS CUI-1
C0015392
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
Is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Ears, nose, throat
Description

Ears, nose, throat

Alias
UMLS CUI-1
C0007222
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant?

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

is the abnormality clinically significant?

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1272696
normal
Description

normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307
abnormal, is the abnormality a new finding?
Description

abnormal new finding

Data type

integer

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2585997
is the abnormality clinically significant?
Description

abnormality clinically significant

Data type

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

Data type

text

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

abnormality clinically significant

Data type

boolean

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

row number

Data type

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 NCT01571583 Physical Examination [FRMPE_PEUNS1]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of examination
C2826643 (UMLS CUI-1)
Item
Date of examination
integer
C2826643 (UMLS CUI [1])
C1320303 (UMLS CUI [2])
Date of examination
Code List
Date of examination
CL Item
Same date as visit date (1)
CL Item
Other date please specify (2)
Other date
Item
if other date, please specify
datetime
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])
Item
Abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
Abnormal
Code List
Abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes, please specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes, please specify: (2)
abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes, specify (2)
abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes, specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes, please specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes please specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes please specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes please specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes please specify (2)
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])
Item
abnormal, is the abnormality a new finding?
integer
C0205161 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
abnormal new finding
Code List
abnormal, is the abnormality a new finding?
CL Item
no (1)
CL Item
yes please specify (2)
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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