ID
13898
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)
- 2016-03-14 2016-03-14 -
Rättsinnehavare
CC BY-NC 3.0
Uppladdad den
14 mars 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Screening Physical Examination
VX-950HPC3006 Screening Physical Examination
- StudyEvent: ODM
Beskrivning
General Appearance
Alias
- UMLS CUI-1
- C1148438
Beskrivning
Not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
Normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
Abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
Skin and mucous membranes
Alias
- UMLS CUI-1
- C1123023
- UMLS CUI-2
- C0026724
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011603
- UMLS CUI [1,2]
- C0439748
Beskrivning
Eyes
Alias
- UMLS CUI-1
- C0015392
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
Funduscopic exam
Alias
- UMLS CUI-1
- C0029090
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
if yes, subject is screening failure
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
date of funduscopic exam
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0029090
- UMLS CUI [1,2]
- C0011008
Beskrivning
Ears, nose, throat
Alias
- UMLS CUI-1
- C0007222
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
Cardiovascular system
Alias
- UMLS CUI-1
- C0007226
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
Respiratory system
Alias
- UMLS CUI-1
- C0035237
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
Gastrointestinal system
Alias
- UMLS CUI-1
- C0012240
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
Genito-urinary system
Alias
- UMLS CUI-1
- C0260313
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
is the abnormality clinically significant?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
neurological system
Alias
- UMLS CUI-1
- C0027853
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
musculo-skeletal system
Alias
- UMLS CUI-1
- C0026860
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
lymph nodes
Alias
- UMLS CUI-1
- C0024204
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
anorectal
Alias
- UMLS CUI-1
- C3870603
Beskrivning
not done
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
normal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beskrivning
abnormal
Datatyp
text
Alias
- UMLS CUI [1]
- C0205161
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
other abnormality
Alias
- UMLS CUI-1
- C1704258
- UMLS CUI-2
- C0205394
Beskrivning
new finding only please only one abnormality per row
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0205394
Beskrivning
abnormality clinically significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beskrivning
row number
Datatyp
text
Alias
- UMLS CUI [1]
- C0237753
Similar models
VX-950HPC3006 Screening Physical Examination
- StudyEvent: ODM
C1320303 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0026724 (UMLS CUI-2)
C2985739 (UMLS CUI [1,2])
C0439748 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])