ID

14112

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2016-03-30 2016-03-30 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

30 mars 2016

DOI

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Licens

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

Engelsk

VX-950HPC3006 NCT01571583 Targeted Physical Examination

1 Formulär  
Date of examination
Beskrivning

Date of examination

Alias
UMLS CUI-1
C2826643
Date of examination
Beskrivning

Date of examination

Datatyp

integer

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

Other date

Datatyp

date

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

General Appearance

Alias
UMLS CUI-1
C1148438
Not done
Beskrivning

Not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
Normal
Beskrivning

Normal

Datatyp

boolean

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

Abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

Skin and mucous membranes

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

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

Eyes

Alias
UMLS CUI-1
C0015392
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

Ears, nose, throat

Alias
UMLS CUI-1
C0007222
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

Cardiovascular system

Alias
UMLS CUI-1
C0007226
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant?

Datatyp

boolean

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

Respiratory system

Alias
UMLS CUI-1
C0035237
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

Gastrointestinal system

Alias
UMLS CUI-1
C0012240
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

Genito-urinary system

Alias
UMLS CUI-1
C0260313
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

is the abnormality clinically significant?

Datatyp

boolean

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

neurological system

Alias
UMLS CUI-1
C0027853
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

musculo-skeletal system

Alias
UMLS CUI-1
C0026860
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

lymph nodes

Alias
UMLS CUI-1
C0024204
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

anorectal

Alias
UMLS CUI-1
C3870603
not done
Beskrivning

not done

Datatyp

boolean

Alias
UMLS CUI [1]
C1272696
normal
Beskrivning

normal

Datatyp

boolean

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

abnormal new finding

Datatyp

integer

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

abnormality clinically significant

Datatyp

boolean

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

other abnormality

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

new finding only please only one abnormality per row

Datatyp

text

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

abnormality clinically significant

Datatyp

boolean

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

row number

Datatyp

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 NCT01571583 Targeted Physical Examination

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
not done (1)
CL Item
same date as visit date (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])
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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